Mechanical Engineer – NPD

Title : Mechanical Engineer – NPD

Location: Dublin, CA

Work Arrangement: Onsite

Experience: 8–12 Years

Job Description

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 experience taking products from concept and prototyping through validation, production release, and design transfer in a regulated medical-device environment.

Key Responsibilities

• Serve as a 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 end-to-end mechanical design activities from concept, feasibility, and prototyping through design freeze and production release.
• Translate user needs, system requirements, 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.
• Ensure compliance with applicable medical-device standards and regulations, including ISO 13485, FDA 21 CFR 820, ISO 14971, and relevant IEC standards.
• Maintain completeness of Design History File (DHF) documentation.
• Lead and participate in dFMEA, pFMEA, and hazard analysis.
• Support design changes through ECO/ECN processes.
• Define mechanical verification strategies and support EVT, DVT, and V&V testing.
• Investigate and resolve mechanical failures identified during testing, manufacturing, and field feedback.
• Lead implementation of DFM/DFA principles.
• Work with suppliers and contract manufacturers on tooling, materials, manufacturing processes, and yield improvement.
• Support FAI, PPAP, pilot builds, and design transfer to manufacturing.
• Drive resolution of manufacturing issues, NCRs, and deviations.
• Collaborate closely with Electronics, Software, Systems, Quality, Regulatory, and Supply Chain teams.
• Lead design reviews, technical discussions, and customer walkthroughs.
• Perform engineering analyses including tolerance stack-ups, hand calculations, and FEA.
• Provide technical input for cost reduction, design optimization, and next-generation product improvements.
• Mentor and technically guide junior and mid-level engineers.

Required Experience

• 8–12 years of Mechanical Design & 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.
• Experience taking products from concept → prototype → validation → production.

Required Technical Skills

• SolidWorks or Creo
• Medical-device materials and manufacturing processes
• Electromechanical integration
• Thermal considerations
• EMI/EMC-aware mechanical design
• Reliability engineering
• GD&T – ASME Y14.5
• Tolerance stack-up
• DFM/DFA
• FEA and engineering calculations
• PLM/QMS systems such as Windchill or Agile
• Medical-device development and regulated product lifecycle processes

Regulatory & Quality Experience

Strong understanding of:

• ISO 13485
• FDA 21 CFR 820
• ISO 14971
• Design History File (DHF)
• dFMEA / pFMEA
• Hazard analysis
• ECO/ECN
• Design verification and validation
• EVT / DVT / V&V
• Design transfer and production release
• NCRs and deviations

Preferred Qualifications

• Experience with Windchill or Agile PLM/QMS.
• EMI/EMC-aware mechanical design experience.
• Thermal management experience.
• Supplier and contract manufacturer management.
• Experience with FAI, PPAP, and pilot builds.
• Experience supporting tooling and manufacturing processes.
• Strong understanding of cost reduction and design optimization.
• Experience conducting design reviews and technical presentations.
• Experience mentoring junior and mid-level engineers.
• Experience integrating motors, sensors, PCBs, batteries, power supplies, connectors, and cable routing.

Education

• Bachelor’s or Master’s degree in Mechanical Engineering or a related engineering discipline.

Ideal Candidate Profile

The ideal candidate will have:

• 8+ years of mechanical design and development experience
• Strong medical-device NPD background
• Hands-on SolidWorks or Creo experience
• Strong mechanical architecture and electromechanical integration skills
• Expertise in GD&T, ASME Y14.5, and tolerance stack-ups
• Strong DFM/DFA and FEA experience
• Experience with ISO 13485, FDA 21 CFR 820, and ISO 14971
• Experience with DHF, FMEA, EVT/DVT, and V&V
• Experience supporting design transfer, pilot builds, FAI/PPAP, and production release
• Strong cross-functional technical leadership experience