Senior Mechanical Engineer - Medical Devices Lead

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

Job summary

Sira Consulting is seeking an experienced Mechanical Design Lead for electromechanical medical device programs in the United States. You will own the mechanical architecture, drive end-to-end design from concept through production release, and ensure compliance with ISO 13485, FDA requirements, and IEC standards.

You will mentor junior engineers and collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering.
• 8–12 years of mechanical design and development experience, medical device NPD preferred.
• Strong CAD skills with SolidWorks or Creo; knowledge of materials and manufacturing processes.

Responsibilities

• Lead mechanical design activities across concept to production release.
• Own mechanical architecture, interfaces, enclosures, mechanisms, and EMI/EMC considerations.
• Develop and review 3D CAD models, drawings, GD&T, and BOMs.
• Ensure integration of motors, sensors, PCBs, batteries, power supplies, connectors, and cabling.
• Ensure compliance with ISO 13485, FDA 21 CFR 820, ISO 14971, and IEC standards; maintain DHF.
• Lead risk management (dFMEA, hazard analysis) with cross-functional teams.
• Support ECO/ECN changes and DVT/EVT/V&V testing.
• Collaborate with suppliers and contract manufacturers on tooling and yield improvements.
• Lead design reviews, technical discussions, and customer walkthroughs.
• Guide tolerance stack-ups and perform engineering analyses; contribute to cost reduction and next-gen improvements.
• Mentor junior engineers.

Skills

Mechanical design leadership

Cross-functional collaboration

Regulatory compliance

Tolerance analysis (GD&T)

DFM/DFA

Thermal management

EMI/EMC integration

FMEA (dFMEA/pFMEA)

Project mentoring

Cost optimisation input

Education

Bachelor’s or Master’s degree in Mechanical Engineering

Tools

SolidWorks or Creo

Job description

Sira Consulting is seeking an experienced Mechanical Design Lead for electromechanical medical device programs in the United States. You will own the mechanical architecture, drive end-to-end design from concept through production release, and ensure compliance with ISO 13485, FDA requirements, and IEC standards.

You will mentor junior engineers and collaborate with electronics, software, systems, quality, regulatory, and supply chain teams.