Principal R&D Engineer

Location: Onsite

Employment Type: Full-Time

We are hiring a Principal R&D Engineer to lead the development of catheter-based medical devices from concept through commercialization. This is a senior, hands-on technical leadership role for an engineer who can independently own programs, drive design strategy, and partner cross-functionally to deliver high-quality, manufacturable products.

• Lead catheter product development from concept through design verification and design transfer
• Serve as technical lead for cross-functional development teams
• Translate clinical and user needs into robust design requirements, specifications, and test methods
• Drive design reviews and ensure timely completion of design control deliverables
• Own verification and validation activities through regulatory clearance
• Design, build, and evaluate prototypes to assess feasibility and performance
• Collaborate closely with Process Development, Manufacturing, Quality, Regulatory, and suppliers
• Identify technical risks and implement mitigation strategies
• Mentor engineers and contribute to technical and product strategy

• Bachelor’s degree in Engineering (advanced degree preferred)
• 7+ years of medical device R&D experience
  , with strong catheter development background
• Proven ownership of products from concept through commercialization
• Deep understanding of design controls and medical device quality systems
• Ability to operate independently with minimal direction
• Proficiency with Solid Works and standard engineering tools

• Regulatory submission support and design transfer experience
• Broad exposure from small-to-mid-sized OEMs or CMOs
• Strong understanding of how design decisions impact manufacturing and validation

This role offers the opportunity to own critical catheter development programs
, influence technical direction, and bring innovative devices to market.