Mechanical Engineer - NPD

Job Title: Mechanical Engineer NPD

Location: Dublin, CA | Onsite

Experience Level: 8 12 Years

Job Summary

We are seeking an experienced Mechanical Engineer NPD to provide technical leadership for mechanical design and development within electromechanical medical device programs . The ideal candidate will have strong medical-device NPD experience and a proven track record taking products from concept and prototyping through validation, production release, and design transfer in a regulated environment.

This role requires expertise in mechanical architecture, electromechanical integration, GD&T, tolerance stack-ups, DFM/DFA, FEA, reliability, and regulated product development , along with the ability to collaborate across engineering, quality, regulatory, manufacturing, and supply chain teams.

Responsibilities

• Serve as Technical Lead for Mechanical Design within electromechanical medical device programs.

• Own mechanical architecture and interfaces for enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.

• Lead mechanical design from concept, feasibility, and prototyping through design freeze and production release.

• Translate system requirements, user needs, and electrical/software constraints into robust mechanical designs.

• Develop and review 3D CAD models, detailed drawings, GD&T, and BOMs.

• Integrate motors, sensors, PCBs, batteries, power supplies, connectors, and cabling into mechanical assemblies.

• Lead and participate in dFMEA, pFMEA, and hazard analysis.

• Define mechanical verification strategies and support EVT, DVT, V&V, and related testing.

• Investigate and resolve failures identified during testing, manufacturing, and field feedback.

• Lead DFM/DFA implementation and support manufacturing readiness.

• Work with suppliers and contract manufacturers on tooling, materials, processes, and yield improvement.

• Support FAI, PPAP, pilot builds, and design transfer to manufacturing.

• Drive resolution of manufacturing issues, NCRs, and deviations.

• Support design changes through ECO/ECN processes.

• Perform tolerance stack-ups, engineering calculations, hand calculations, and FEA.

• Ensure completeness of Design History File (DHF) documentation and compliance with applicable medical-device requirements.

• Collaborate with Electronics, Software, Systems, Quality, Regulatory, and Supply Chain teams.

• Lead design reviews, technical discussions, and customer walkthroughs.

• Provide technical input for cost reduction, design optimization, and next-generation product improvements.

• Mentor and technically guide junior and mid-level engineers.

Required Qualifications

• Bachelor's or Master's degree in Mechanical Engineering.

• 8 12 years of mechanical design and development experience.

• Significant experience in medical device new product development (NPD) .

• Proven experience leading electromechanical product development through the full product lifecycle in a regulated environment.

• Strong proficiency with SolidWorks or Creo .

• Experience with medical-device materials and manufacturing processes.

• Strong knowledge of mechanical architecture and electromechanical integration .

• Experience with GD&T and ASME Y14.5 .

• Strong tolerance stack-up experience.

• Hands-on knowledge of DFM/DFA .

• Experience with FEA and engineering calculations .

• Experience with reliability engineering.

• Knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 .

• Experience with FMEA, DHF, EVT/DVT, V&V, and design transfer.

Preferred Qualifications

• Experience with Windchill or Agile PLM/QMS .

• EMI/EMC-aware mechanical design experience.

• Thermal management experience.

• Experience with ECO/ECN processes.

• Supplier and contract manufacturer management experience.

• Experience with FAI, PPAP, and pilot builds.

• Experience handling NCRs and deviations.

• Experience leading design reviews and cross-functional technical discussions.

• Experience with tooling and manufacturing process development.

Work Requirements

• This is an onsite position in Dublin, California .

• Candidates should be able to work collaboratively with cross-functional engineering, manufacturing, quality, regulatory, and supply chain teams.

Equal Opportunity Employer

We are committed to providing equal employment opportunities to all qualified candidates and maintaining an inclusive workplace free from discrimination and harassment.

Application

Qualified candidates with strong medical-device mechanical NPD experience are encouraged to apply.