Lead mechanical product development for implantable and wearable medical devices from concept through commercial release, guiding technical decisions and cross-functional execution. Support verification, validation, failure analysis, manufacturing readiness, regulatory compliance, and product launches while mentoring engineers and coordinating with suppliers and stakeholders.
Requirements:
- Requires a bachelor's degree in mechanical engineering, biomedical engineering, or a related discipline, plus at least eight years of medical device product development experience and a record of leading products through commercialization.
- Candidates should have electromechanical development experience, proficiency with Creo and/or SolidWorks, knowledge of design controls and verification and validation, and demonstrated technical leadership; implantable device experience and a master's degree are preferred.
Key Skills:
- Mechanical Product Development
- Electromechanical Systems
- Medical Device Development
- Technical Leadership
- Product Requirements
- Technical Specifications
- Design Reviews
- Verification and Validation
- Failure Analysis
- Manufacturing Readiness
- FDA and ISO Compliance
- Design Controls
- Creo
- SolidWorks
- Risk Management
- FMEA
Benefits:
- Medical Insurance
- Dental Insurance
- Vision Coverage
- Paid Leave
Principal Mechanical Design Engineer in california at Unknown Company
This position is listed as full time and onsite.