Sr. Engineer, Design Development, R&D
Teleflex, Wyomissing, PA, United States
About Teleflex Incorporated. As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose‑driven innovation, and world‑class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Vascular & Emergency Medicine. Built on a legacy of innovation and clinical excellence, the Vascular & Emergency Medicine business at Teleflex develops and delivers advanced medical technologies that empower clinicians to help improve patient outcomes and optimize healthcare efficiency. Our trusted Arrow™, Arrow™, EZ‑IO™, and QuikClot™ brands set the standard for vascular access and emergency medicine, offering proven solutions to enhance patient outcomes. From technically advanced vascular access devices – including central venous and arterial catheters, PICCs, and sheath introducers with antimicrobial protection – to life‑saving intraosseous access systems and hemostatic technologies used by hospitals, EMS, and military teams worldwide, our portfolio embodies precision, reliability, and performance. As part of a high‑performing, purpose‑driven organization, we are united by a commitment to clinical differentiation, innovation, and excellence. Join a dynamic, growth‑focused team that offers advanced medical technology solutions that make a lasting impact on healthcare.
Position Summary
The Sr. Design Engineer leads end‑to‑end development of advanced vascular access devices from early concept through commercialization and design transfer. This role integrates clinical insight, engineering rigor, and regulatory compliance to deliver innovative, manufacturable, and high‑quality products. Operating within a matrixed organization, the Sr. Design Engineer partners with Technical Experts and Project Managers to ensure alignment to business objectives, timelines, and portfolio strategy while serving as a technical leader across disciplines.
Responsibilities
Concept Development
Translate clinical needs, market insights, and user feedback into clear user needs and design inputs
Lead concept generation, feasibility studies, and early risk reduction activities
Develop and evaluate innovative design concepts using engineering fundamentals and simulation
Conduct clinical observations and collaborate with clinicians to refine use cases and requirements
Lead early‑stage DFMEA, UFMEA, and feasibility testing to guide design direction
Design and Development
Develop detailed design and development plans, identifying deliverables, gaps, and contingencies.
Lead detailed design of complex systems including mechanical, fluid, and material interactions including establishment of associated transfer functions
Develop CAD models, simulations, and engineering analyses to optimize performance
Provide material selection expertise including polymers and metals, with sterilization compatibility.
Drive design for manufacturability, sterilization compatibility, and reliability
Own requirements traceability from user needs through design outputs; ensuring audit readiness and manufacturability.
Lead usability engineering activities and human factors integration
Guide subsystem integration and system‑level architecture decisions
Verification, Validation & Compliance
Lead cross‑functional teams in execution of robust design verification strategies.
Develop and execute design verification and validation strategies aligned with regulatory expectations
Own documentation of test methods and lead test method validation studies.
Ensure compliance with FDA and Teleflex design controls, ISO 13485, and ISO 14971
Author and review DHF documentation ensuring audit readiness
Support regulatory submissions including 510(k) and PMA
Lead risk management activities and ensure mitigation effectiveness
Design Transfer & Manufacturing
Collaborate with manufacturing to ensure robust design transfer and scalability
Support process development and validation activities (IQ/OQ/PQ)
Ensure alignment between design intent and manufacturing capability
Participate in PFMEA and support production readiness and pilot builds
Drive resolution of design‑related issues during transfer and launch
Comply with Teleflex’s Code of Ethics, all company policies, rules, procedures and housekeeping standards.
Behavioral Competencies
Systems thinking and ability to integrate cross‑disciplinary inputs
Advanced problem‑solving and root cause analysis
Strong understanding of design controls and regulatory compliance
Ability to translate ambiguous clinical needs into structured engineering requirements
Technical leadership and cross‑functional influence
Risk‑based decision making and prioritization
Effective communication with technical and non‑technical stakeholders
Adaptability and ownership in a fast‑paced development environment
Education / Experience Requirements
Bachelor of Science – Engineering or equivalent technical discipline
Preferred: Master of Science – Engineering or equivalent technical discipline
Minimum of 10 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
Specialized Skills / Other Requirements
Technical Knowledge
Deep expertise in mechanical systems, fluid dynamics, and material properties as applied to vascular access and interventional devices, with the ability to apply first‑principles engineering to develop and evaluate early‑stage design concepts
Ability to translate clinical workflows, user needs, and market insights into structured engineering requirements and design inputs, enabling development of innovative, patient‑centric solutions
Advanced capability in concept generation, feasibility assessment, and simulation‑driven design, including development of analytical and computational models to evaluate performance, usability, and risk during early design phases
Strong application of Design for Manufacturability (DFM), Design for Assembly (DFA), and usability/ergonomic principles from concept through development to ensure scalable and robust product designs
Demonstrated expertise in early‑stage risk identification and mitigation, including application of DFMEA, UFMEA, and hazard analysis to guide concept selection and design refinement
Strong command of verification and validation methodologies, with the ability to define testable design inputs and ensure traceability from concept through validation in alignment with ISO 14971 risk management principles
Ability to design and interpret advanced statistical analyses (e.g., DOE, tolerance analysis, feasibility data interpretation) to support concept down‑selection, design optimization, and performance characterization
Regulatory and Compliance
In‑depth knowledge and application of design control processes and global regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820, EU MDR) in medical device development
Leads design verification and validation activities, ensuring alignment with regulatory expectations, risk management, and usability engineering principles
Owns and drives change control activities, including ECOs, CAPA, and design changes, ensuring compliance and traceability across the DHF
Process Development and Manufacturing Support
Leads process development and validation activities, including defining and supporting IQ, OQ, and PQ strategies in collaboration with manufacturing and quality teams
Drives PFMEA and risk assessment activities, ensuring alignment between design intent and manufacturing capability
Applies deep understanding of material behavior and manufacturing processes to optimize product performance, consistency, and yield
Project Management and Collaboration
Authors and reviews complex technical documentation, including design history files (DHF), verification protocols/reports, and regulatory submissions
Leads cross‑functional collaboration across R&D, Quality, Regulatory, Manufacturing, and Clinical teams, influencing decisions and driving alignment
Communicates complex technical concepts effectively to diverse audiences, including leadership and external stakeholders
Demonstrates advanced analytical thinking and structured problem‑solving, leading root‑cause investigations and implementing robust solutions
Exhibits strong leadership, collaboration, and mentoring capabilities within a matrixed organization
Highly proficient in engineering tools, data analysis platforms, and design/simulation software
Demonstrated expertise in polymer component design and catheter‑based systems, including application to vascular access or interventional devices
Self‑motivated, high‑energy, positive attitude individual with the initiative and drive for timely completion of goals. Able to travel domestically and internationally.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877‑880‑8588 or Talent@Teleflex.com.
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Vascular & Emergency Medicine. Built on a legacy of innovation and clinical excellence, the Vascular & Emergency Medicine business at Teleflex develops and delivers advanced medical technologies that empower clinicians to help improve patient outcomes and optimize healthcare efficiency. Our trusted Arrow™, Arrow™, EZ‑IO™, and QuikClot™ brands set the standard for vascular access and emergency medicine, offering proven solutions to enhance patient outcomes. From technically advanced vascular access devices – including central venous and arterial catheters, PICCs, and sheath introducers with antimicrobial protection – to life‑saving intraosseous access systems and hemostatic technologies used by hospitals, EMS, and military teams worldwide, our portfolio embodies precision, reliability, and performance. As part of a high‑performing, purpose‑driven organization, we are united by a commitment to clinical differentiation, innovation, and excellence. Join a dynamic, growth‑focused team that offers advanced medical technology solutions that make a lasting impact on healthcare.
Position Summary
The Sr. Design Engineer leads end‑to‑end development of advanced vascular access devices from early concept through commercialization and design transfer. This role integrates clinical insight, engineering rigor, and regulatory compliance to deliver innovative, manufacturable, and high‑quality products. Operating within a matrixed organization, the Sr. Design Engineer partners with Technical Experts and Project Managers to ensure alignment to business objectives, timelines, and portfolio strategy while serving as a technical leader across disciplines.
Responsibilities
Concept Development
Translate clinical needs, market insights, and user feedback into clear user needs and design inputs
Lead concept generation, feasibility studies, and early risk reduction activities
Develop and evaluate innovative design concepts using engineering fundamentals and simulation
Conduct clinical observations and collaborate with clinicians to refine use cases and requirements
Lead early‑stage DFMEA, UFMEA, and feasibility testing to guide design direction
Design and Development
Develop detailed design and development plans, identifying deliverables, gaps, and contingencies.
Lead detailed design of complex systems including mechanical, fluid, and material interactions including establishment of associated transfer functions
Develop CAD models, simulations, and engineering analyses to optimize performance
Provide material selection expertise including polymers and metals, with sterilization compatibility.
Drive design for manufacturability, sterilization compatibility, and reliability
Own requirements traceability from user needs through design outputs; ensuring audit readiness and manufacturability.
Lead usability engineering activities and human factors integration
Guide subsystem integration and system‑level architecture decisions
Verification, Validation & Compliance
Lead cross‑functional teams in execution of robust design verification strategies.
Develop and execute design verification and validation strategies aligned with regulatory expectations
Own documentation of test methods and lead test method validation studies.
Ensure compliance with FDA and Teleflex design controls, ISO 13485, and ISO 14971
Author and review DHF documentation ensuring audit readiness
Support regulatory submissions including 510(k) and PMA
Lead risk management activities and ensure mitigation effectiveness
Design Transfer & Manufacturing
Collaborate with manufacturing to ensure robust design transfer and scalability
Support process development and validation activities (IQ/OQ/PQ)
Ensure alignment between design intent and manufacturing capability
Participate in PFMEA and support production readiness and pilot builds
Drive resolution of design‑related issues during transfer and launch
Comply with Teleflex’s Code of Ethics, all company policies, rules, procedures and housekeeping standards.
Behavioral Competencies
Systems thinking and ability to integrate cross‑disciplinary inputs
Advanced problem‑solving and root cause analysis
Strong understanding of design controls and regulatory compliance
Ability to translate ambiguous clinical needs into structured engineering requirements
Technical leadership and cross‑functional influence
Risk‑based decision making and prioritization
Effective communication with technical and non‑technical stakeholders
Adaptability and ownership in a fast‑paced development environment
Education / Experience Requirements
Bachelor of Science – Engineering or equivalent technical discipline
Preferred: Master of Science – Engineering or equivalent technical discipline
Minimum of 10 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
Specialized Skills / Other Requirements
Technical Knowledge
Deep expertise in mechanical systems, fluid dynamics, and material properties as applied to vascular access and interventional devices, with the ability to apply first‑principles engineering to develop and evaluate early‑stage design concepts
Ability to translate clinical workflows, user needs, and market insights into structured engineering requirements and design inputs, enabling development of innovative, patient‑centric solutions
Advanced capability in concept generation, feasibility assessment, and simulation‑driven design, including development of analytical and computational models to evaluate performance, usability, and risk during early design phases
Strong application of Design for Manufacturability (DFM), Design for Assembly (DFA), and usability/ergonomic principles from concept through development to ensure scalable and robust product designs
Demonstrated expertise in early‑stage risk identification and mitigation, including application of DFMEA, UFMEA, and hazard analysis to guide concept selection and design refinement
Strong command of verification and validation methodologies, with the ability to define testable design inputs and ensure traceability from concept through validation in alignment with ISO 14971 risk management principles
Ability to design and interpret advanced statistical analyses (e.g., DOE, tolerance analysis, feasibility data interpretation) to support concept down‑selection, design optimization, and performance characterization
Regulatory and Compliance
In‑depth knowledge and application of design control processes and global regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820, EU MDR) in medical device development
Leads design verification and validation activities, ensuring alignment with regulatory expectations, risk management, and usability engineering principles
Owns and drives change control activities, including ECOs, CAPA, and design changes, ensuring compliance and traceability across the DHF
Process Development and Manufacturing Support
Leads process development and validation activities, including defining and supporting IQ, OQ, and PQ strategies in collaboration with manufacturing and quality teams
Drives PFMEA and risk assessment activities, ensuring alignment between design intent and manufacturing capability
Applies deep understanding of material behavior and manufacturing processes to optimize product performance, consistency, and yield
Project Management and Collaboration
Authors and reviews complex technical documentation, including design history files (DHF), verification protocols/reports, and regulatory submissions
Leads cross‑functional collaboration across R&D, Quality, Regulatory, Manufacturing, and Clinical teams, influencing decisions and driving alignment
Communicates complex technical concepts effectively to diverse audiences, including leadership and external stakeholders
Demonstrates advanced analytical thinking and structured problem‑solving, leading root‑cause investigations and implementing robust solutions
Exhibits strong leadership, collaboration, and mentoring capabilities within a matrixed organization
Highly proficient in engineering tools, data analysis platforms, and design/simulation software
Demonstrated expertise in polymer component design and catheter‑based systems, including application to vascular access or interventional devices
Self‑motivated, high‑energy, positive attitude individual with the initiative and drive for timely completion of goals. Able to travel domestically and internationally.
Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877‑880‑8588 or Talent@Teleflex.com.
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