Sr. Engineer, Design Development, R&D

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.

Principal Responsibilities

•    Concept Development
o    Translate clinical needs, market insights, and user feedback into clear user needs and design inputs
o    Lead concept generation, feasibility studies, and early risk reduction activities
o    Develop and evaluate innovative design concepts using engineering fundamentals and simulation
o    Conduct clinical observations and collaborate with clinicians to refine use cases and requirements
o    Lead early-stage DFMEA, UFMEA, and feasibility testing to guide design direction
•    Design and Development
o    Develop detailed design and development plans, identifying deliverables, gaps, and contingencies.
o    Lead detailed design of complex systems including mechanical, fluid, and material interactions including establishment of associated transfer functions
o    Develop CAD models, simulations, and engineering analyses to optimize performance
o    Provide material selection expertise including polymers and metals, with sterilization compatibility.
o    Drive design for manufacturability, sterilization compatibility, and reliability
o    Own requirements traceability from user needs through design outputs; ensuring audit readiness and manufacturability.
o    Lead usability engineering activities and human factors integration
o    Guide subsystem integration and system-level architecture decisions
•    Verification, Validation & Compliance
o    Lead cross-functional teams in execution of robust design verification strategies.
o    Develop and execute design verification and validation strategies aligned with regulatory expectations
o    Own documentation of test methods and lead test method validation studies.
o    Ensure compliance with FDA and Teleflex design controls, ISO 13485, and ISO 14971
o    Author and review DHF documentation ensuring audit readiness
o    Support regulatory submissions including 510(k) and PMA
o    Lead risk management activities and ensure mitigation effectiveness
•    Design Transfer & Manufacturing
o    Collaborate with manufacturing to ensure robust design transfer and scalability
o    Support process development and validation activities (IQ/OQ/PQ)
o    Ensure alignment between design intent and manufacturing capability
o    Participate in PFMEA and support production readiness and pilot builds
o    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.

#LI-DR1