Mechanical Engineer – NPD

Intellectt INC; Dublin (CA); On-site; USD 140,000 - 180,000; Full time

Job summary

Intellectt INC in Dublin, CA is seeking an experienced Mechanical Engineer NPD to lead mechanical design and development for electromechanical medical device programs. You will drive from concept through validation, production release and design transfer in a regulated environment.

The role requires expertise in mechanical architecture, electromechanical integration, GD&T, tolerance stack‑ups, DFM/DFA, FEA, reliability, and regulatory product development, with collaboration across engineering,

Qualifications

• 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.

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 DHF documentation and compliance with 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.

Skills

Mechanical design

Electromechanical integration

GD&T

Tolerance analysis

DFM/DFA

FEA

Reliability engineering

SolidWorks/Creo

Regulatory compliance

Project leadership

Mentoring

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Creo

Windchill/Agile PLM/QMS

Job description

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.