Mechanical Engineer - NPD

Sira Consulting, an Inc 5000 company; Dublin (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Sira Consulting, an Inc 5000 company, seeks a senior mechanical design lead for electromechanical medical device programs. You will own architecture, interfaces, and integration of enclosures, mechanisms, and thermal paths, ensuring EMI/EMC compliance.

Responsibilities include leading design activities through concept, feasibility, DVT/EVT, and production release, translating requirements into robust mechanical designs, and mentoring junior engineers.

Qualifications

• 8–12 years of mechanical design experience in medical devices.
• Experience leading mechanical development of electromechanical products through full lifecycle in regulated environments.

Responsibilities

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own the mechanical architecture and interfaces for subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
• Lead end-to-end mechanical design activities from concept through production release.

Skills

CAD proficiency

EMI/EMC-aware design

Thermal analysis

GD&T ASME Y14.5

FEM/FEA

PLM/QMS tools

Education

B.S./M.S. Mechanical Engineering

Tools

SolidWorks

Creo

Windchill

Agile

Job description

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own the mechanical architecture and interfaces for electro‑mechanical subsystems including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
• Lead end‑to‑end mechanical design activities from concept, feasibility, and prototyping to 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.
• Ensure proper integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling within mechanical assemblies.
• Execute development activities in compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and applicable IEC standards.
• Ensure completeness and quality of Design History File (DHF) documentation.
• Lead and participate in risk management activities (dFMEA, pFMEA, hazard analysis) with cross‑functional teams.
• Support design changes through formal ECO/ECN processes.
• Define mechanical verification strategies and support DVT, EVT, and V&V testing.
• Investigate and resolve failures observed during testing, manufacturing, or field feedback.
• Lead application of DFM/DFA principles for manufacturing processes.
• Work closely 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 related to mechanical design.
• Collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.
• Lead and participate in design reviews, technical discussions, and customer walkthroughs.
• Guide and perform engineering analyses including tolerance stack‑ups (hand calculations and FEA).
• Provide technical input for cost reduction, design optimization, and next‑generation improvements.
• Mentor and technically guide junior and mid‑level engineers.

Experience

• 8–12 years of experience in mechanical design and development, with significant experience in medical device NPD.
• Proven experience leading mechanical development of electromechanical products through full product lifecycle in regulated environments.

Required Technical Skills

• Strong proficiency in CAD tools such as SolidWorks or Creo.
• In‑depth knowledge of materials and manufacturing processes for medical devices.
• Strong understanding of electromechanical integration, thermal considerations, EMI/EMC‑aware mechanical design, and reliability.
• Expertise in GD&T (ASME Y14.5), tolerance stack‑up, and DFM/DFA.
• Knowledge of FEA and practical engineering calculations.
• Familiarity with PLM and QMS tools such as Windchill, Agile.

Qualification:

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