Mechanical Engineer NPD

Mechanical Engineer - NPD

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:

• Bachelors or Masters degree in Mechanical Engineering.

Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development Projects Requirements Analysis Software Design Software Implementation Efficient Build Release Process and turnkey software V & V Services. We have more than 20 years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment connected vehicles Cyber security OTA and Advanced Safety/ Body electronics.