Mechanical Engineer – NPD

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Systems Ally
Chicago, IL, United States
  • Healthcare

Locals Preffered!!

Genuine profiles only!!

Technical Leadership & System Ownership

  • 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.
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