remote
Principal Engineer, NPD, Advanced Innovation and Technology - Edwards Lifesciences
Software Engineer
Lead the design and development of next‑generation structural heart devices, driving innovation from concept to market while collaborating across engineering, regulatory, and manufacturing teams.
About the role
Key Responsibilities
- Lead the end‑to‑end product development lifecycle for advanced structural heart solutions, from ideation through prototype, testing, and regulatory submission.
- Drive innovation by integrating emerging technologies, materials, and design methodologies into new device concepts.
- Collaborate closely with cross‑functional teams—including design, manufacturing, quality, and regulatory—to ensure product feasibility, manufacturability, and compliance.
- Mentor and coach junior engineers, fostering a culture of continuous improvement and technical excellence.
- Represent the engineering team in executive reviews, providing strategic insights and progress updates on R&D initiatives.
Requirements
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field; advanced degree preferred.
- 10+ years of experience in medical device development, with a strong focus on structural heart products.
- Proven track record of leading multidisciplinary teams through successful product launches.
- Deep understanding of regulatory pathways (FDA, CE) and quality systems (ISO 13485).
- Excellent communication, problem‑solving, and leadership skills.
Skills
agileautocadsix sigma