Location: Onsite Employment Type: Full-Time
We are seeking a Principal R&D Engineer to lead catheter-based medical device development from concept through commercialization. This is a senior technical leadership role responsible for end-to-end product ownership, driving design strategy, leading cross-functional teams, and ensuring successful design transfer into manufacturing. The ideal candidate brings deep catheter expertise, strong design control rigor, and the ability to independently drive complex programs with minimal oversight.
Lead product development activities from concept through commercialization in compliance with Quality System and design control requirements
Serve as technical lead and primary contributor for cross-functional development teams
Translate user, patient, and clinical needs into verified and validated device designs through robust requirements, specifications, and test methods
Drive conceptualization, design, development, and refinement of catheter devices and product line extensions
Own verification and validation activities through regulatory clearance and design transfer
Lead and facilitate design reviews; ensure timely completion of all design control deliverables
Design, assemble, and evaluate prototype devices to assess feasibility and performance
Develop robust test methods, fixtures, and protocols to evaluate materials, components, and designs
Collaborate closely with Process Development, Manufacturing, Quality, Regulatory, and suppliers to ensure scalable, manufacturable designs
Manage multiple projects simultaneously while maintaining schedules and acting as a primary technical point of contact for leadership
Identify technical risks early and implement effective mitigation strategies
Interface professionally with physicians and external partners while maintaining confidentiality and IP vigilance
Contribute to product portfolio strategy, continuous improvement initiatives, and departmental process enhancements
Mentor engineers and, where applicable, manage direct reports
Bachelor’s degree in Engineering or related technical field (advanced degree preferred)
7+ years of medical device R&D experience, including significant catheter development experience
Proven ownership of full product development lifecycles from concept through design verification and commercialization
Deep understanding of design controls, quality systems, and medical device regulatory requirements
Strong analytical and problem-solving skills with the ability to work independently
Excellent written and verbal communication skills
Proficiency with CAD tools (SolidWorks preferred) and standard engineering software
Familiarity with statistical techniques and engineering study documentation
Hands-on experience with common lab equipment (e.g., calipers, micrometers, tensile testers, pressure testers, vision systems)
Advanced knowledge of catheter materials and manufacturing processes (e.g., extrusion, injection molding, machining, tooling, adhesive and thermal bonding)
Demonstrated expertise in generating new catheter designs, materials, processes, test methods, and metrology
Experience supporting regulatory submissions and design transfer to manufacturing
Background in small-to-mid-sized OEMs or CMOs with broad technical exposure
Demonstrated ability to lead and mentor technical personnel
This role offers the opportunity to own high-impact catheter development programs, influence technical and product strategy, and play a key role in bringing innovative medical devices to market. You’ll work in a collaborative environment that values hands-on technical leadership, disciplined execution, and design
