remote
Lead R&D Engineer, Sustaining Engineering - Hollister Incorporated
Software Engineer
Senior R&D engineer leading the design, development, and commercialization of medical devices, driving concepts from clinical need through prototype, verification, validation, and sustained product support.
About the role
Key Responsibilities
- Lead technical development of new medical device concepts, from early clinical need assessment through prototype creation.
- Design, model, and iterate mechanical components using SolidWorks and other CAD tools.
- Plan and execute verification and validation activities, ensuring compliance with FDA and ISO standards.
- Collaborate with R&D, quality, regulatory, and manufacturing teams to transition prototypes to commercial production.
- Provide technical mentorship and guidance to junior engineers, fostering best‑practice engineering processes.
Requirements
- Bachelor’s or higher in Mechanical Engineering, Biomedical Engineering, or related field with 8+ years of medical device development experience.
- Proven expertise in mechanical design, rapid prototyping, and CAD (SolidWorks preferred).
- Hands‑on experience with design verification, validation, and regulatory submissions (FDA 510(k), ISO 13485).
- Strong problem‑solving skills and ability to work autonomously in cross‑functional environments.
- Excellent communication and leadership abilities to drive projects to commercialization.
Skills
agilemechanical engineeringautocadproject management