Product Development Engineer
Core
Execute New Product Development for surgical implants, prosthetics, and instruments through concept, design, verification, and transfer to production.
Role type
Product Development Engineer (Medical Devices)
Builds
Surgical implants, prosthetics, and instruments
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features
Required skills
Mechanical or Biomedical Engineering background, 3D CAD modeling (SolidWorks), Geometric Dimensioning & Tolerancing (GD&T), Finite Element Analysis, statistical analysis, risk management (FMEA), biocompatibility and sterilization evaluation, technical writing, vendor coordination
Preferred skills
Experience in highly regulated industries
Technologies
SolidWorks, ISO 13485, FDA 21CFR Part 820.30, ISO-14971, ISO 10993-1, ISO 11737, ASME Y14.5
Responsibilities
Generate product development documentation ensuring regulatory compliance, conduct risk management activities (FMEA), perform biocompatibility and sterilization evaluations, review part dimensions and materials, approve engineering drawings, develop engineering protocols and reports, coordinate new product introductions
Seniority
Mid-level, hands-on IC