What are the responsibilities and job description for the Mechanical Engineer position at Prism IT Global?
Responsibilities
- Lead mechanical design activities for electromechanical medical device development programs.
- Own mechanical architecture and subsystem integration including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations.
- Translate system requirements, user needs, and electrical/software constraints into robust mechanical designs.
- Develop and review 3D CAD models, engineering drawings, GD&T, and BOMs.
- Integrate motors, sensors, PCBs, batteries, power supplies, connectors, and cabling into mechanical assemblies.
- Ensure compliance with FDA regulations, ISO 13485, ISO 14971, and applicable IEC standards.
- Maintain Design History File (DHF) documentation.
- Lead risk management activities including DFMEA, PFMEA, and hazard analysis.
- Support engineering change management through ECO and ECN processes.
- Define verification strategies and support EVT, DVT, and V&V testing activities.
- Investigate design, testing, manufacturing, and field failures and implement corrective actions.
- Apply DFM/DFA principles to optimize manufacturing readiness.
- Collaborate with suppliers and contract manufacturers on tooling, materials, processes, and yield improvements.
- Support FAI, PPAP, pilot builds, and manufacturing transfer activities.
- Resolve NCRs, deviations, and manufacturing issues related to mechanical design.
- Work closely with electrical, software, systems, quality, regulatory, and supply chain teams.
- Participate in design reviews, technical discussions, and customer meetings.
- Perform engineering analyses including tolerance stack-ups and FEA.
- Support cost reduction, design optimization, and next-generation product development initiatives.
- Mentor and guide junior engineers.
Required Qualifications
- Bachelor's degree in Mechanical Engineering or related discipline.
- 8–12 years of mechanical product development experience.
- Significant experience developing medical devices in regulated environments.
- Strong experience with electromechanical systems integration.
- Expertise in CAD modeling, GD&T, tolerance analysis, and mechanical design.
- Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC standards.
- Experience with DFMEA, PFMEA, risk management, DFM/DFA, and manufacturing transfer.
- Proven success leading products through the full development lifecycle from concept through production release.