Principal Delivery System Design Engineer : 1st Gen Structural Heart Innovation

Principal Delivery System Design Engineer : 1st Gen Structural Heart Innovation

This is an exciting opportunity to take ownership of designing and developing a novel transcatheter delivery system and implant therapy. As an R&D Engineer, you will be empowered to make critical design decisions, rapidly prototype, and quickly iterate in a fast‑paced startup environment.

You’ll work hands‑on in the lab while also shaping system‑level integration, ensuring our technology advances efficiently from concept through clinical readiness. If you thrive on creativity, ownership, and driving innovation under tight timelines, this role offers the chance to make a direct impact on future patients’ lives while helping shape our growing R&D team. Final title will depend on experience.

• Design, prototype, and evaluate proof‑of‑concept designs for novel transcatheter delivery system and implant therapy.
• Lead hands‑on prototyping, bench testing, and preclinical animal studies (design, execution, and evaluation).
• Work closely with implant development team to ensure system‑level integration.
• Design and develop products in compliance with Design Control, FDA, ISO, and MDR requirements.
• Think creatively to solve technical challenges and innovate within limited budgets and timelines.
• Identify design issues and track root causes.
• Collaborate with clinical advisors and KOLs to translate clinical needs into design solutions.
• Develop protocols/reports and perform verification and validation testing (in‑vitro and in‑vivo).
• Maintain knowledge of competitive technologies and industry developments in cardiovascular devices.
• Provide regular updates of key milestones and issues to project teams and management.
• Contribute leadership and mentorship as the R&D team expands.

• Bachelor’s degree in Mechanical or Biomedical Engineering with 5+ years’ medical device engineering experience.
• Strong knowledge of catheter device design, material selection, and testing.
• Experience with structural heart (percutaneous valve replacement/repair) implantable devices strongly preferred.
• Expertise in delivery system–implant integration and structural/tissue dynamics strongly preferred.
• Understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Hands‑on builder with prototyping and troubleshooting skills.
• Animal study experience (design, leadership, and/or execution).
• Bonus:
  Clinical exposure (training physicians, case support, imaging analysis).
• Effective communication skills across technical teams, management, and physicians.
• Demonstrated ability to mentor junior engineers and provide technical leadership.
• Ability to thrive in a fast‑paced, lean startup environment, balancing multiple priorities.
• Proficiency in CAD (Solid Works preferred); familiarity with DOE and statistical tools a plus.

Mid‑Senior level

Full‑time

Medical Equipment Manufacturing and Biotechnology Research

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