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Mechanical Engineer NPD

Ztek Consulting INC

Job Location:

Dublin, VA - USA

Monthly Salary: Not provided by the employer

Posted: 21 June 2026 (30+ days ago)

Application Deadline: 18 September 2026

Vacancies: 1 Vacancy

Job Summary

Job Title: Mechanical Engineer - NPD

Location: Dublin CA - Onsite

Type of Hire: Full-time or Contract

Responsibilities:

Act as a 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