Mechanical Engineer
Creative Solutions Services, LLC
Roles & Responsibilities:
- 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.
Requirements:
- 8+ 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.
- Bachelor's or Master's degree in Mechanical Engineering.
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.
Vacancy posted 21 hours ago
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