MedTech Mechanical Engineer
Zenith Services Inc. · Palo Alto, CA · 3 wk ago
On-siteEngineeringFull-time
About the role
The successful candidate will be responsible for designing, developing, and improving innovative medical products within the Medical Device industry.
Responsibilities
- Create and maintain engineering drawings, specifications, and design documentation
- Develop prototypes and support design iterations based on testing results
- Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Suppliers
- Support verification testing, validation activities, and product releases
- Identify design risks and provide engineering solutions
- Participate in product improvements, cost reduction initiatives, and sustaining engineering activities
- Ensure designs meet regulatory, safety, and performance requirements
Requirements
- 5+ years of experience as a Mechanical Engineer in the Medical Device / MedTech industry
- Strong experience designing and developing medical devices, surgical instruments, diagnostic equipment, or electromechanical medical systems
- Hands-on experience with mechanical design, 3D modeling, assemblies, and detailed drawings
- Proficiency with CAD tools such as SolidWorks, Creo, CATIA, or similar
- Strong knowledge of GD&T, tolerance stack-up analysis, and engineering drawings
- Experience with Design Verification and Validation (DV/V) testing
- Knowledge of ISO 13485 quality systems and medical device development processes
- Experience with DFM/DFA, injection molding, plastics, machining, and manufacturing processes
- Ability to perform root cause analysis, failure analysis, and corrective actions
- Experience supporting ECO/ECN processes and product changes
Qualifications
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field
- Must-have keywords: Medical Device, MedTech, Mechanical Design, Product Development, FDA, ISO 13485, Design Controls, DV/V, SolidWorks, Creo, GD&T, DFM, FMEA, Prototyping, Injection Molding, Sustaining Engineering, Risk Management
Skills
- Experience with Class II / Class III medical devices
- Experience with FDA submissions, DHF (Design History File), DMR documentation
- Experience with biocompatible materials and medical-grade plastics
- Experience with disposable medical devices, implants, robotics, wearables, or surgical products
Benefits
N/A
Pay
N/A
Schedule
N/A