Lead Mechanical Engineer - MedTech Electromechanical Systems

JobDiva, Inc.; Indianapolis (IN); On-site; USD 105,000 - 140,000; Full time

Job summary

JobDiva, Inc. seeks a seasoned Mechanical Design Lead for electromechanical medical device programs in Indianapolis. You will own the mechanical architecture and interface with electronics, power, and cabling, guiding design through concept, feasibility, and production release.

You will apply GD&T, create CAD models, perform analyses, and manage DHF documentation under ISO 13485 and FDA 21 CFR 820. Collaboration with suppliers and manufacturing is essential to ensure robust DFM/DFA.

Qualifications

• 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.

Responsibilities

• Act as technical lead for mechanical design within electromechanical medical device programs.
• Own the mechanical architecture and interfaces for subsystems including enclosures, mechanisms, and EMI/EMC considerations.
• Lead end-to-end mechanical design activities from concept to production release.
• Translate user needs and constraints into robust mechanical designs.
• Develop and review 3D CAD models, detailed drawings, GD&T, and BOMs.
• Lead and participate in design reviews and risk management activities with cross-functional teams.
• Define mechanical verification strategies and support testing and validation.

Skills

Mechanical design

NPD medical devices

Leadership

Regulatory compliance

DFM/DFA

Risk analysis

Cross-functional collaboration

Design reviews

Education

Bachelor's or Master's in Mechanical Engineering

Tools

SolidWorks

Creo

FEA

Job description

JobDiva, Inc. seeks a seasoned Mechanical Design Lead for electromechanical medical device programs in Indianapolis. You will own the mechanical architecture and interface with electronics, power, and cabling, guiding design through concept, feasibility, and production release.

You will apply GD&T, create CAD models, perform analyses, and manage DHF documentation under ISO 13485 and FDA 21 CFR 820. Collaboration with suppliers and manufacturing is essential to ensure robust DFM/DFA.