Overview
We are seeking a highly experienced Mechanical Design Engineer with a deep technical background in the design and development of implantable neurostimulation leads for active implantable medical devices. The ideal candidate has over 10 years of hands-on experience driving innovative solutions across spinal cord, brain, and peripheral nerve stimulation therapies. The candidate should have extensive experience working with SolidWorks.
Responsibilities
- Drive end-to-end development of implantable neurostimulation leads, from concept through commercialization.
- Drive design efforts including materials selection, electrical and mechanical layout, manufacturability, and biocompatibility.
- Collaborate cross-functionally with systems engineering, regulatory, quality, and manufacturing teams.
- Support design verification/validation (DV/DT), pre-clinical testing, and design transfer to manufacturing.
- Ensure compliance with ISO 13485, IEC 60601, and FDA Class III device regulations.
Qualifications
- 10+ years of experience in medical device R&D, including implantable neurostimulation systems.
- SolidWorks experience 5+ years
- Proven track record in development of leads for spinal cord, brain (DBS), or peripheral nerve stimulation.
- Expertise in biocompatible materials, electrical interfaces, and active implant assembly processes.
- Familiarity with risk management (ISO 14971), DFMEA, and design controls.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
- Engineering, Manufacturing, and Production
Industries
- Medical Equipment Manufacturing and Biotechnology Research
Benefits
- Medical insurance
- Vision insurance
- 401(k)