Mechanical Engineer

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

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.