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Job Description We’re looking for a motivated and collaborative Product Development Engineer to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment. We're excited to provide a complete benefits package, including a comprehensive health plan, 401(k), and professional development opportunities, to support the well-being and growth of our employees and their families. POSITION SUMMARY This position’s primary responsibility is to lead technical aspects of new product development and/or re-design of existing disposable medical devices to support the Company’s research and development goals. This person will execute technical and cross-functional project work which may include efforts in all phases of research & product development, including research, design and development planning, requirements definition, solid modeling, root cause analysis, test method development/validation, and design verification/validation activities. This person will support efforts to improve product quality and manufacturing processes and will support continuous improvement initiatives. This job description is intended to cover multiple levels within the same role. Level and responsibilities will commensurate with the individual’s experience and qualifications. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Product Design & Development • Design and develop medical devices and components in compliance with design control requirements (e.g., 21 CFR 820, ISO 13485)., • Generate and maintain design documentation including requirements, risk analyses, drawings, specifications, and design history files (DHF)., • Perform tolerance analysis, material selection, and design for manufacturability., • Source and purchase test and production equipment, develop equipment PM and calibration requirements, and complete test method validations. Risk Management & Quality • Participate in risk management activities, including hazard analysis, FMEA, and risk mitigation., • Lead or support design reviews and ensure traceability from user needs through verification and validation., • Investigate and resolve design‑related nonconformances, complaints, and CAPAs. Cross‑Functional Collaboration • Collaborate with Manufacturing Engineering to transfer designs into production, facilitate change management documentation, develop, troubleshoot and maintain manufacturing process equipment and systems., • Collaborate with business stakeholders, including medical, commercial, marketing and operations to understand business and market needs., • Collaborate with Regulatory Affairs to support submissions., • Support supplier development, qualification, and technical communication. Testing & Documentation • Develop and execute verification and validation test protocols, including test methods., • Perform data analysis and design of experiments and present results to technical and non‑technical stakeholders. Maintain accurate records in accordance with company procedures and regulatory requirements. Continuous Improvement • Identify opportunities to improve product performance, reliability, and cost., • Apply lessons learned and post‑market feedback to next‑generation designs. SUPERVISORY RESPONSIBILITIES The Product Development Engineer may have supervisory responsibilities for other members of the engineering group and may need to supervise temporary product testers, as required. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION/EXPERIENCE/SKILLS Education • Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, or a related field., • A minimum of 8 years medical device research & development experience may substitute for degree Experience • 3-5 years of product development experience, preferably in the medical device or regulated industry., • Experience working under formal design controls and quality systems. Technical Skills • Proficiency in SolidWorks (CAD), • Proficiency in Microsoft Office (Word, Excel, Project), Smartsheets, and Minitab, • Knowledge of materials, manufacturing processes, and medical device testing methods., • Familiarity with applicable standards (ISO 13485, ISO 14971, FDA QMSR). Soft Skills • Strong analytical and problem‑solving skills., • Effective written and verbal communication., • Self-starter with the ability to work independently and within cross‑functional teams., • Solid organizational skills with the ability to anticipate and adapt to changing situations. LANGUAGE SKILLS Ability to read and interpret documents such as prints, technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine protocols/reports and correspondence. Ability to speak effectively with employees and outside organizations. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.

Job Description Are you ready to work for a company that truly cares about making a meaningful difference in this world? A little about us: Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets. We create sustainable flexibility that delivers maximum impact to make people’s lives better. It's pretty cool stuff! What we can offer you: In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our employees: • Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!, • Comprehensive Dental + Vision, • 401k Retirement Plan that we match up to 3%, • Basic Life AD&D Insurance, • Employee Assistance Program, • Paid time off - 18 days first year (pro-rated), • Paid holidays – 9 days, • Annual Performance Bonus Potential, • Employee Profit Sharing, • Tuition Assistance, • Employee Appreciation Events, • $100 Hannaford Gift Card every November, • Annual Praxis Hoodie for all employees, • Bagel Tuesdays! Position Summary: The Manufacturing Engineering Manager is responsible for leading the Manufacturing Engineering team in support of operational excellence, quality, continuous improvement, new product introduction, and manufacturing scalability. This leadership role provides strategic direction and technical oversight for manufacturing processes, equipment, process validation, lean initiatives, and engineering projects that drive business growth and operational performance. The Manufacturing Engineering Manager partners closely with Operations, Quality, Supply Chain, Program Management, and Senior Leadership to improve safety, quality, delivery, productivity, and cost. This position is accountable for developing a high-performing engineering team while ensuring manufacturing processes comply with customer requirements, regulatory standards, and Praxis Technology's Quality Management System (QMS). The ideal candidate is a hands-on leader with strong engineering expertise, a passion for developing people, and a commitment to Praxis Technology's Core Values: Dependable, Genuinely Care, Team Player, Driven to Improve, and Own It. How you will make an impact: • Lead continuous improvement initiatives focused on improving safety, quality, delivery, productivity, and cost., • Lead, mentor, and develop a team of Manufacturing Engineers and technical personnel to achieve departmental and organizational objectives., • Lead engineering support for CAPA investigations, nonconformances, process improvements, and audit findings, • Establish clear performance expectations, development plans, and succession strategies for engineering team members., • Monitor key manufacturing performance indicators and prioritize improvement opportunities.Champion waste reduction, standardization, visual management, and process optimization initiatives across the organization., • Develop and execute the manufacturing engineering strategy to support business growth, operational excellence, and customer satisfaction.Lead continuous improvement initiatives focused on safety, quality, delivery, productivity, capacity, and cost reduction., • Utilize Lean Manufacturing, Six Sigma, and data-driven methodologies to drive, • Ensure efficient transfer and scale-up of new products into production.Lead process design reviews, risk assessments, and manufacturing readiness activities.Support capacity planning, labor optimization, and equipment utilization improvements., • Partner with Operations teams to solve complex manufacturing challenges and eliminate production constraints., • Foster a culture of accountability, innovation, collaboration, and continuous improvement., • Provide coaching and technical guidance to support employee growth and professional development.Build organizational capability through cross-training, knowledge sharing, and leadership development., • Ensure manufacturing engineering activities comply with Praxis Technology's Quality Management System., • Lead engineering support for CAPA investigations, nonconformances, process improvements, and audit findings, • Provide engineering leadership for new product launches and manufacturing transfer activities.Collaborate with customers, program managers, quality, and operations teams to ensure successful implementation of new programs., • Evaluate manufacturing risks and develop mitigation plans that ensure successful product commercialization., • Ensure team compliance with OSHA requirements and company safety policies Education, Experience, and Technical Competencies • Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Plastics Engineering, Chemical Engineering, Industrial Engineering, or a related technical discipline., • 10+ years of manufacturing engineering experience preferred., • 5+ years of engineering leadership, • Experience in a regulated manufacturing environment preferred, including medical device, aerospace, defense, or other highly controlled industries., • Familiarity with ISO 9001, ISO 13485, and AS9100 standards preferred., • Experience utilizing statistical methods and data analysis to improve process capability, yield, and quality., • Demonstrated success implementing lean manufacturing and continuous improvement methodologies, • Experience leading root cause analysis and CAPA investigations using structured problem-solving techniques., • Extensive experience implementing Lean Manufacturing and continuous improvement methodologies.

Job Description Are you ready to work for a company that truly cares about making a meaningful difference in this world? Culture Join a team that makes innovations reality, owns the process and demands excellence all while supporting your work-life balance with flexible schedules, ample vacation time to rest and recharge, and a relaxed atmosphere so you can focus on what matters — doing good work that makes people’s lives better. We value people that are highly motivated, self-starters open to learning new things every day. We’re looking for people with a good attitude and strong character who strive to be the best at what they do, take accountability for their actions and are determined and committed to get the job done. Benefits We’re a company that values you and your career path and recognizes the importance of work-life balance. In addition to being part of a locally owned and operated business who values treating everyone with integrity and respect, we offer the following benefits to our employees: • Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!, • Comprehensive Dental + Vision, • 401k Retirement Plan that we match up to 3%, • Basic Life AD&D Insurance, • Employee Assistance Program, • Paid time off — 18 days first year (pro-rated), • Paid holidays — 9 days, • Annual Performance Bonus Potential, • Employee Profit Sharing, • Tuition Assistance, • Shift differential: 2nd shift – + $1/hr, 3rd shift – + $3/hr We pride ourselves on being a community-minded company that provides lots of opportunity to learn, grow and be at your best every day. Position Summary Reporting to Quality Manager, the Quality Engineering Technician plays a crucial role in ensuring the production of high-quality products while maintaining and improving our quality management systems to meet regulatory requirements. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive attitude, and strong commitment to quality. How You’ll Make an Impact • Perform root cause investigations of non-conformities; implementing corrective and preventative actions to prevent recurrence., • Support Corrective and Preventive Actions (CAPA) to continuously improve the quality management system., • Maintain the computerized maintenance management system by entering new equipment and equipment changes., • Support the calibration program by ensuring timely completion calibrations., • Create and implement effective quality controls by establishing monitoring, sampling, and inspection methods., • Lead and participate in the development and implementation of quality systems, records, and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies., • Support internal audits to assess the effectiveness of the quality management systems., • Conduct regular inspections and audits to identify defects, deviations, or non-compliance issues., • Provide training and support to employees to ensure adherence to quality standards., • Support external audits from regulatory bodies and customers., • Identify, champion and support continuous improvement projects in quality, productivity, and/or safety., • Support quality metrics trending and analysis., • Perform lot history record review, releasing manufacturing lots and issuing certificates of conformance to customers., • Serve as a subject matter expert in quality assurance on cross-functional teams ensuring compliance to the compliance with applicable regulatory requirements, standards, and company policies. What You Must Bring to This Role • Minimum two (2) years experience working in a Quality Department in a manufacturing environment., • Experience within Medical Device or other regulated industries preferred., • Strong analytical and problem-solving skills, • Familiarity with quality management systems and tools, • Detail-oriented with a focus on root cause analysis, • Excellent interpersonal skills, with ability to collaborate with and support all levels of associates, • Demonstrated ability to assess priority, complete tasks, and work independently, • Demonstrated verbal and written communication skills, organized and effective technical writing, • Working knowledge of ISO 13485 Working Conditions & Physical Efforts • Work is performed in a Production environment, • May be required to lift up to 50 lbs., • Ability to stand or sit for a prolonged period of time, • Visual functions being those of acceptable or corrected near vision, depth perception, and ability to adjust focus, • Talking and hearing occur continuously in the process of communicating with associates, leadership & suppliers, • Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment, • Moderate exposure to physical risk Praxis is an equal opportunity employer

Job Description Are you ready to work for a company that truly cares about making a meaningful difference in this world? A little about us: Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets. We create sustainable flexibility that delivers maximum impact to make people’s lives better. It's pretty cool stuff! What we can offer you: In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our employees: • Employee and/or Employee + Child(ren) medical insurance costs you just $1/month!, • Comprehensive Dental + Vision, • 401k Retirement Plan that we match up to 3%, • Basic Life AD&D Insurance, • Employee Assistance Program, • Paid time off - 18 days first year (pro-rated), • Paid holidays – 9 days, • Annual Performance Bonus Potential, • Employee Profit Sharing, • Tuition Assistance, • Employee Appreciation Events, • $100 Hannaford Gift Card every November, • Annual Praxis Hoodie for all employees, • Bagel Tuesdays! Position Summary: The Manufacturing Engineer plays a critical role in advancing operational excellence, manufacturing scalability, product quality, and continuous improvement across Praxis Technology's manufacturing operations. This position is responsible for developing, optimizing, and sustaining manufacturing processes while driving yield improvement, cost reduction, problem solving, and equipment effectiveness initiatives. The Manufacturing Engineer leads root cause analysis activities, corrective and preventive actions (CAPA), process validation efforts, and lean manufacturing initiatives to improve operational performance and customer satisfaction. This role partners closely with Operations, Quality, Engineering, and Supply Chain teams to support new product introductions, process improvements, and manufacturing scalability in a regulated environment. The ideal candidate demonstrates strong technical expertise, a continuous improvement mindset, and a commitment to Praxis Technology's Core Values: Dependable, Genuinely Care, Team Player, Driven to Improve, and Own It. How you will make an impact: • Lead continuous improvement initiatives focused on improving safety, quality, delivery, productivity, and cost., • Drive yield improvement and cost reduction projects through data analysis, process optimization, and waste elimination., • Develop, implement, and sustain lean manufacturing practices including 5S, visual management, value stream mapping, standard work, Kanban systems, and mistake-proofing techniques., • Evaluate manufacturing metrics and identify opportunities to improve product quality, throughput, and overall equipment effectiveness (OEE)., • Lead efforts to reduce variation, scrap, rework, and manufacturing inefficiencies., • Develop, document, validate, and improve manufacturing processes to ensure repeatability, efficiency, and compliance., • Support the transfer, scale-up, and launch of new products into manufacturing., • Coordinate manufacturing readiness activities for new product introductions and process changes., • Implement and evaluate process improvements designed to enhance quality, productivity, capacity, and operational performance., • Provide hands-on engineering support to resolve manufacturing challenges and production bottlenecks., • Lead root cause investigations for production, quality, and customer-related issues using structured problem-solving methodologies., • Develop and implement effective Corrective and Preventive Actions (CAPA) to prevent recurrence of issues., • Support nonconformance investigations, risk assessments, and continuous improvement activities., • Ensure compliance with customer, regulatory, and internal quality requirements., • Participate in process validations, equipment qualifications, and change control activities., • Provide technical leadership, coaching, and mentoring to operators, technicians, and manufacturing personnel., • Develop and deliver effective training programs, work instructions, and manufacturing documentation., • Improve the accuracy, effectiveness, and usability of manufacturing procedures, work instructions, and production records., • Foster a culture of accountability, teamwork, and continuous learning throughout the manufacturing organization., • Partner with equipment manufacturers, tooling suppliers, and material vendors to resolve process and equipment-related issues., • Support equipment upgrades, preventive maintenance improvements, and capacity expansion initiatives., • Participate in vendor evaluations and qualification activities as needed., • Maintain compliance with Praxis Technology's Quality Management System (QMS)., • Support compliance with ISO 9001, ISO 13485, AS9100, customer requirements, and applicable regulatory standards., • Promote a safe work environment by adhering to OSHA requirements and safety best practices., • Support a culture of quality, compliance, and operational excellence throughout the organization. Education, Experience, and Technical Competencies • Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Plastics Engineering, Chemical Engineering, Industrial Engineering, or a related technical discipline., • 5+ years of manufacturing engineering experience preferred., • Experience in a regulated manufacturing environment preferred, including medical device, aerospace, defense, or other highly controlled industries., • Familiarity with ISO 9001, ISO 13485, and AS9100 standards preferred., • Experience utilizing statistical methods and data analysis to improve process capability, yield, and quality., • Demonstrated success implementing lean manufacturing and continuous improvement methodologies, • Experience leading root cause analysis and CAPA investigations using structured problem-solving techniques.

Job Description The Quality Engineer is responsible for supporting and maintaining the Quality Management System (QMS) within a regulated medical device manufacturing environment. This role leads and supports validation activities, internal audits, nonconformance investigations, environmental monitoring review, and risk management activities. The Quality Engineer partners closely with Engineering, Manufacturing, and Quality teams to ensure compliance, drive continuous improvement, and support successful product development and transfer to production. Performance is evaluated based on quality of work, timeliness, productivity, adherence to procedures, regulatory compliance, safety performance, and contribution to continuous improvement initiatives. ESSENTIAL DUTIES AND RESPONSIBILITIES Safety & Compliance • Promote and maintain a strong safety culture, ensuring adherence to all site safety policies and procedures, • Comply with applicable regulatory requirements including FDA QSR, ISO 13485, ISO 14971, OSHA, EPA, and internal quality system requirements, • Maintain compliance with Good Manufacturing Practices (cGMP) and ensure regulatory readiness in all assigned activities Quality Systems & Regulatory Compliance • Support maintenance and continuous improvement of the Quality Management System (QMS), • Ensure timely and compliant execution of quality system processes and documentation control, • Evaluate compliance trends and recommend improvements to strengthen system effectiveness Validation & Process Development Support • Develop, review, and approve validation protocols and final reports (IQ/OQ/PQ as applicable), • Review experimental and process development documentation for completeness and compliance, • Support transfer of new products from development into manufacturing, ensuring alignment with specifications and quality requirements, • Participate in process improvement and validation lifecycle activities Nonconformance, CAPA & Disposition Activities • Review and approve nonconformance investigations and material dispositions (MRB activities), • Approve rework plans and ensure compliance with defined quality requirements, • Support root cause analysis and corrective/preventive action (CAPA) investigations, • Review defect threshold investigations and associated data analysis, • Ensure timely closure and effectiveness verification of assigned CAPAs Risk Management (PFMEA) • Develop, maintain, and update Process Failure Mode and Effects Analyses (PFMEAs), • Collaborate with Engineering and Manufacturing to identify risks and implement mitigation strategies, • Ensure risk management documentation aligns with ISO 14971 principles and product lifecycle requirements Internal Auditing & Quality Monitoring • Plan, conduct, and document internal audits across manufacturing and support functions, • Track audit findings and ensure timely closure of corrective actions, • Generate audit reports and support regulatory and customer audits as needed, • Review environmental monitoring data and investigate excursions beyond established limits Customer & Manufacturing Support • Assist with customer complaint investigations and technical response activities, • Partner with Manufacturing and Engineering to resolve quality issues and improve process capability, • Support daily production activities through participation in meetings and real-time issue resolution Training & Continuous Improvement • Support employee training related to quality systems and compliance requirements, • Participate in continuous improvement initiatives and cross-functional projects, • Lead or support assigned quality and operational improvement projects Documentation & Reporting • Create and maintain controlled quality system documentation, including validation records and risk assessments, • Generate and track special handling documentation and quality records as required, • Maintain accurate and complete records in compliance with regulatory requirements SUPERVISORY RESPONSIBILITIES • None QUALIFICATIONS REQUIREMENTS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made. Education & Experience • High school diploma or GED required, • Associate or Bachelor's degree in Engineering, Science, or related technical field preferred, • 5–7 years of experience in medical device manufacturing or regulated manufacturing environment required, • Strong knowledge of cGMP and ISO 13485 requirements required, • Working knowledge of ISO 14971 risk management principles required Technical Skills • Proficient in Microsoft Office (Word, Excel, PowerPoint, Project), • Experience with statistical tools and data analysis techniques preferred, • Familiarity with ERP and quality systems preferred, • Strong technical writing and documentation skills Communication Skills • Strong verbal and written communication skills across all organizational levels, • Ability to present technical information clearly and effectively, • Ability to facilitate cross-functional discussions and training sessions, • Strong collaboration skills with Engineering, Manufacturing, and Quality teams Mathematical & Analytical Skills • Ability to work with basic mathematical concepts including addition, subtraction, multiplication, division, fractions, and decimals, • Ability to analyze data trends using spreadsheets and statistical tools, • Ability to interpret quality data and identify process variation Reasoning Ability • Ability to apply logical thinking to solve problems and interpret technical instructions, • Ability to make sound, data-driven decisions in a regulated environment, • Ability to manage multiple priorities and independently execute tasks PHYSICAL DEMANDS • Must be able to analyze data in multiple formats and systems, • Must be able to make independent decisions related to quality and compliance, • May be required to lift and/or move up to 50 pounds, • Ability to work in both office and controlled manufacturing environments WORK ENVIRONMENT • Primarily office-based with periodic exposure to manufacturing environments, • Manufacturing areas may require PPE such as hairnets, smocks, gloves, and safety glasses, • Exposure to controlled environments and low-level chemical or solvent odors may occur, • Work environment is generally well-lit and temperature controlled

Job Description Are you ready to work for a company that truly cares about making a meaningful difference in this world? A little about us: Praxis Technology is a manufacturing company that designs and develops titanium parts for medical devices, aerospace and other consumer markets.We create sustainable flexibility that delivers maximum impact to make people’s lives better. It's pretty cool stuff! We value people that are highly motivated, self-starters, open to learning new things every day. We look for like-minded individuals who will embrace the five core values of Praxis: • Team player, • Driven to improve, • Genuinely care, • Dependable, • Own What we can offer you: In addition to being part of a locally owned & operated business who values treating everyone with integrity & respect, we offer the following benefits to our full-time employees: • Employee and/or Employee + Child(ren) medical insurance for just $1/month!, • Comprehensive Dental + Vision, • 401k Retirement Plan that we match up to 3%, • Basic Life AD&D Insurance, • Employee Assistance Program, • Paid time off - 18 days first year (pro-rated), • Paid holidays – 9 days, • Annual Performance Bonus Potential & Profit Sharing Program, • Employee Profit Sharing, • Tuition Assistance, • We are currently unable to sponsor applicants for this role. Position Summary Reporting to Quality Manager, the Quality Engineer is responsible for projects and support of production. The Quality Engineer leads and supports improvements to ensure the consistent quality of product. The Quality Engineer maintains, analyzes and improves Praxis Technology’s Quality Management System to meet customer’s expectations, company objectives and applicable regulations and standards. The ideal candidate must be able to work independently and as a team, have a strong work ethic, a positive & supportive attitude, with a strong commitment to quality. How You’ll Make an Impact • Lead and participate in the development and implementation of quality systems and procedures to ensure compliance with applicable regulatory requirements, standards, and company policies., • In house knowledge expert of Praxis parts and processes. Train, audit, and support others in production tasks and methods., • Determine and complete qualification activities for new products and processes and perform tests according to protocols and procedures., • Lead the equipment maintenance and calibration programs., • Lead non-conforming material investigations, corrective and preventive actions, internal audits and training programs by analyzing data, creating tools, determining risks and gaps, managing data and reporting., • Lead and participate in supplier selection, evaluation, and qualification processes to ensure that suppliers meet quality standards and regulatory requirements., • Develop and maintain supplier quality agreements, and lead and participate in supplier audits to ensure that suppliers are meeting quality requirements., • Conduct quality reviews of the Device History Record. Ensure production documents (record sheets, material labels, shipping paperwork) are complete and accurate., • Evaluate incoming materials, and supplier processed materials into production. Examine documents and material for differences, report findings internally and to suppliers, and complete material disposition., • Review certification documents for final release to shipping., • Investigate and resolve discrepancies. Document resolution, findings and actions via memos, reports., • Identify, champion and support improvement projects (LEAN and Six Sigma) in quality, productivity, and/or safety., • Define and draft new procedures, engineering specifications, reports and record sheets. Review and support the release of new documents. Review and revise documents for change control., • Create spreadsheets, internal standards and methods to improve output and consistency. Create and implement quality controls, process sampling, and inspection procedures., • Maintain compliance with Praxis’ Quality Management System., • Ensure compliance with OSHA guidelines and apply best practices for on-the-job safety in a production environment., • Adhere to quality assurance procedures and processes while maintaining an orderly production facility., • Continually mentor and develop the quality engineering and quality control team while fostering working relationship with and between team members., • Serve as a subject matter expert in quality assurance and participate in cross-functional teams to support product development, improvement, and release. What You Must Bring to This Role • Bachelor’s Degree in engineering or other applicable area, • 5+ years of experience in a quality role in support of the medical device or aerospace related industry, • Excellent interpersonal skills, with ability to collaborate with and support all levels of associates, • Demonstrated ability to assess priority, complete tasks, work independently and proactively, • Proven attention to detail and focus in an active environment - required, • Demonstrated verbal and written communication skills, organized and effective technical writing, • Proven success working in a team environment, • Working knowledge of statistical techniques, and data analysis, • Experience in application of risk evaluation, root cause analysis, and CAPA tools for improvement and corrective analysis, • Demonstrated experience with measurement devices such as calipers, micrometers, optical measuring system, • Experience in writing production, quality and safety procedures and/or qualification protocols and documents, • Experience in supplier control, including supplier selection, evaluation, qualification, and auditing., • Proven history working with Quality System Regulation, Good Manufacturing Practices and ISO 13485, • Working knowledge of ISO 9001 and/or AS9100 - desired, • Demonstrated experience applying improvement methods, such as lean manufacturing principles and/or Six Sigma training, • Experience leading Internal and/or external audits, • Working knowledge of MasterControl or an electronic QMS, • ASQ certification We are currently unable to sponsor applicants for this role. Working Conditions & Physical Efforts • Work is performed in a Production environment, • May be required to lift up to 50 lbs., • Ability to stand or sit for a prolonged period of time, • Visual functions being those of acceptable or corrected near vision, depth perception, and ability to adjust focus, • Talking and hearing occur continuously in the process of communicating with associates, leadership & suppliers, • Finger dexterity is needed to access, enter, and retrieve data using a computer keyboard or operate equipment, • Moderate exposure to physical risk Praxis is an equal opportunity employer

Job Description POSITION SUMMARY The Quality Engineer is responsible for supporting the effective establishment and maintenance of the Delcath Quality System and ensuring that the facility is fully compliant to all applicable FDA, ISO regulations and the Medical Device Directives/Regulations. The Quality Engineer provides QA support for the company by working with the Quality Assurance Manager to assure proper GMP compliance within Delcath Systems. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. • Maintain effectiveness of the Quality Management System through the resolution of quality concerns and related issues., • Develop and maintain Quality System procedures, including those governing quality control processes and product specifications, • Lead continuous improvements projects., • Participate on new product design teams as the design assurance engineer., • Implement and maintain risk management activities throughout the product lifecycle, including risk analysis (UFMEA, DFMEA, PFMEA) and control measures., • Ensure proper creation, maintenance, and review of Technical Files and Design History Files (DHF) in compliance with regulatory requirements and design control processes., • Perform and support design verification/validation, process validation, software validation and test method validation., • Lead root cause investigations to identify issues and drive effective corrective actions., • Conduct non-conformance activities, including containment, investigation, and disposition., • Support the Corrective Action and Preventive Action Program., • Support the Supplier Quality Program, including supplier evaluations, supplier corrective actions, and on-site quality audits., • Conduct calibration investigation failures on equipment., • Conduct customer complaint investigations., • Support the Internal Audit Program through the performance of audits., • Perform data and statistical trend analysis and support quality monitoring and metrics., • Provides oversight for product releases, including finished products, raw materials, packaging components, and labeling. The Quality Engineer has no supervisory responsibilities. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, unless they constitute undue hardship. EDUCATION and/or EXPERIENCE • Bachelor’s degree in engineering or physical sciences is preferred., • A minimum of two or more years of experience in quality assurance, quality engineering, or related functions in an FDA regulated industry or ISO certified organization is required, • Must be team oriented, with the ability to work well with diverse cross-functional teams., • Must possess strong analytical and process skills, and be computer proficient in EXCEL, Word, etc. Experience with Minitab is preferred., • Must possess strong verbal and written communication skills., • Must be willing to travel. LANGUAGE SKILLS Ability to read and interpret documents such as technical journals, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively with employees and outside organizations. MATHEMATICAL SKILLS Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit, stand or walk and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms; and is subject to repetitive motions of the wrists, hands, and/or fingers. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, heat, airborne particles, moderate noise and outside weather conditions.

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Development experience: 10+ years in software engineering with 3+ years of hands-on engineering experience in Rust development and a proven track record of shipping code that enables the team to maintain healthy, interruption-free nights. Senior Rust Software Engineer. As a Software Engineer with e

ImagineSoftware is growing, and we are inviting a passionate, detail-oriented Software Engineer to come join us! The Software Engineer will develop our clearinghouse and reconciliation product offerings. Our Software Engineers are experts at creating solutions with the end-user experience in mind.

We’re looking for a senior software engineer with deep frontend expertise to help build the best-in-class AI travel management platform. Proactively identifies ways to simplify workflows, reduce engineering effort, and improve maintainability. Wants to set, maintain, and adhere to high engineering

Software Support Engineers support our engineering organization with customer field issues by debugging problems and creating and deploying code patches. At Vicon, we are building the security and monitoring solutions of the future through inventive product design and innovative engineering. Vicon i

The Software Engineer UI/UX is a skilled UI/UX Developer with experience spanning web and mobile platforms. This role bridges design and engineering — you’ll translate product goals and complex workflows into intuitive, high-performance user experiences. Bachelor’s degree in Computer science,

Perform code reviews for other engineers on the team. Document the work you have done both in repo as well as outside of the repo for future engineers. Collaborate with other engineers both verbally and in writing to plan, design, and build a world-class financial research platform.

DevOps Engineer - NextGen Multi-Access Edge Computing (MEC). We need devOps Engineer who understand benchmarking and can develop test strategy to benchmark the solution from network latency, to app latency all the way.

HII, Mission Technologies is seeking self-motivated, talented Software Engineers to design, develop, and test command, control, and communications software for leading edge ISR, SDR, and EW DoD products. Software Engineer 2 - $82,000 - $130,000. Software Engineer 3 - $101,000 - $160,000.

Develops and validates information needed for engineering analyses and applies engineering judgment to solve complex technical problems. The Senior Electrical Engineer position will be responsible for planning and executing activities within the NY TLD/BES Program, specifically supporting engineerin

The engineer works closely with broadcast engineering, IT networking teams, and production staff to maintain highly reliable media infrastructure supporting executive-level studio productions. Broadcast IP Infrastructure Engineer (SMPTE 2110). The Broadcast IP Infrastructure Engineer is responsible

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in a related technical, engineering or science field and a minimum of 6 years of relevant experience; or Masters degree from an accredited college or university in a related technical, engineering o

Process Engineer Job Duties: Oversees and assesses existing processes and workflows.

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in Electrical or Computer Engineering and a minimum of 4 years of relevant experience; or Masters degree from an accredited college or university in Electrical or Computer Engineering and a minimum

The group is responsible for integrating the development and design work across multiple disciplines, including plant engineers in the mechanical, electrical, I&C areas, reactor design and protection engineers, component engineers, etc. Required Combination of Knowledge and Skill Bachelors degree fr

Electrical Engineer Job Duties: Evaluates electrical systems, products, components, and applications by designing and conducting research programs; applying knowledge of electricity and materials. Pr

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in electrical, mechanical or systems engineering and a minimum of 6 years of relevant experience; or Masters degree from an accredited college or university in electrical, mechanical or systems engi

Accomplishes engineering and organization mission by completing related results as needed. Operations Engineer Job Duties: Identifies operational problems by observing and studying system functioning and

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in a related engineering or science field; or Masters degree from an accredited college or university in a related engineering or science field. Looking for a lifetime career? Apply today! Job Descr

Develop plans for surface transportation projects, according to established engineering standards and state or federal construction policy.

Preferred Skills Degree(s) from an accredited college in Chemical Engineering, Ceramic Engineering or Materials Science and Engineering (or similar) Experience in Materials science, control systems and chemical engineering. Required Combination of Knowledge and Skill Bachelors degree from an accredi

Work alongside other engineers on the team to elevate technology and consistently apply best practices. Collaborate cross-functionally with data scientists, business users, project managers and other engineers to achieve elegant solutions.

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in a related technical, engineering or science field and a minimum of 9 years of relevant experience; or Masters degree from an accredited college or university in a related technical, engineering o

Civil Engineer Job Duties: Completes construction projects by preparing engineering design and documents and confirming specifications. Creates feasibility study by analyzing engineering desi

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in a related technical, engineering or science field and a minimum of 6 years of relevant experience; or Masters degree from an accredited college or university in a related technical, engineering o

Staff Software Engineer Remote Job Duties: • Implement and evolve a Data Lake storage system with low latency and high throughput for bulk data ingestion and query • Implement metadata, data governance, security, and acce

If you're interested in diverse job opportunities, career growth, and training that will broaden your technical skills while tackling exciting and challenging assignments, apply TODAY! As a national asset, NNL provides employees with competitive pay and benefits as well as excellent work-life balanc

System Engineer Job Duties: Manages and monitors all installed systems and infrastructure for the organization to be in line with company guidelines or SOP (standard operating procedure).

Preferred Skills Prior Navy experience with nuclear propulsion plant operations (ship or prototype) Background in submarine plant engineering or previous plant or prototype qualification Degree in Mechanical, Chemical, Naval Architecture/Marine, or Systems Engineering is preferred; other engineering

Field Service Engineer - Medical Imaging (Metro NYC / Tri-State Area). Field Service Engineer - Medical Imaging (Metro NYC / Tri-State Area).

Required Combination of Knowledge and Skill Bachelors degree from an accredited college or university in a related technical, engineering or science field and a minimum of 6 years of relevant experience; or Masters degree from an accredited college or university in a related technical, engineering o