Mechanical Engineer - NPD

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

• 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.