What are the responsibilities and job description for the Sr. Product Development Engineer position at One Life Science?
Job Title: Senior Product Development Engineer – Heart Valves
Department: R&D / Product Development
Reports To: Director of Engineering / VP of R&D
About Us
Our client is an early-stage medical device start-up dedicated to transforming the future of structural heart disease treatment. We are developing next-generation heart valve technologies to address critical unmet clinical needs and improve patient outcomes worldwide. Backed by leading investors and guided by a team of industry veterans, we are building something truly meaningful—and we’re looking for a passionate, inventive, and experienced engineer to join us on the journey.
Position Summary
As a Senior Product Development Engineer, you will play a key role in the design, development, and testing of our transcatheter heart valve platform. You’ll lead cross-functional activities from concept through early-stage development, feasibility, and into clinical readiness. This is a high-impact role with the opportunity to shape product architecture, iterate on device design, and collaborate closely with physicians, R&D, manufacturing, and regulatory teams.
Key Responsibilities
- Lead design and development of heart valve systems (e.g. delivery catheter).
- Translate clinical needs into design inputs and functional specifications.
- Develop prototypes and iterate designs using CAD, FEA, and hands-on bench work.
- Plan and execute verification and validation (V&V) testing, including durability, hydrodynamic, and fatigue testing.
- Collaborate with cross-functional teams to guide the product through design controls, risk management (FMEA), and regulatory pathways .
- Manage relationships with suppliers, test labs, and manufacturing partners.
- Support preclinical testing, including bench models and animal studies.
- Document design history in accordance with Quality Management System (QMS) requirements.
- Mentor junior engineers and contribute to building a strong, collaborative team culture.
Qualifications
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
- 7–10 years of experience in medical device product development, preferably in structural heart or cardiovascular devices.
- Proven experience with Class III implantable devices and familiarity with relevant standards
- Strong background in design for manufacturability (DFM), catheter-based delivery systems, and materials such as Nitinol and biocompatible polymers.
- Skilled in SolidWorks (or equivalent), prototyping, and design iteration.
- Hands-on, self-motivated, adaptable, and thrives in a fast-paced start-up environment.
- Experience with design controls, risk analysis, and regulatory submissions is highly desirable.
- Excellent communication, problem-solving, and collaboration skills.
Nice to Have
- Experience with heart valve leaflet design and tissue processing..
- Previous experience working in a start-up or early-stage company.
What We Offer
- Opportunity to work on life-saving technology from the ground up.
- Collaborative and mission-driven culture.
- Competitive salary equity package.
- Health, dental, vision, and other start-up perks.
- Growth opportunities as the company scales.