Principal Medical Device Mechanical Engineer

engineeringjobs.net, Inc.; Franklin (TN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Life & AD&D

Disability coverage

401(k) match

HSA/FSA

Job summary

engineeringjobs.net, Inc. is seeking a Principal/Senior Mechanical Engineer to lead design, development, and optimization of complex medical devices and combination products from concept through launch.

The role requires deep medical device expertise, strong product development and risk management skills, and the ability to mentor other engineers while delivering on schedule and budget in a fast-paced environment.

Qualifications

• Bachelor's degree in Mechanical Engineering required; master's preferred.
• 8 years of dedicated mechanical design experience with at least 5 years in medical devices.
• Expert-level proficiency in CAD and solid modeling (SolidWorks or equivalent).
• Deep knowledge of medical device design controls and standards (ISO 13485, ISO 14971, ISO 60601).
• Ability to work independently, analyze data rigorously, and manage multiple priorities.

Responsibilities

• Lead mechanical architecture and detailed design of complex medical devices using CAD and simulation tools.
• Translate user needs into functional requirements and prototypes using advanced manufacturing techniques.
• Perform tolerance analysis, GD&T, FEA/CFD, and kinematic modeling for reliability in clinical environments.
• Develop and execute Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820.
• Partner with manufacturing, quality, and supply chain to optimize design for manufacturability, assembly, and cost.
• Drive risk management per ISO 14971 including hazard analysis, FMEA, and root-cause investigations.
• Provide technical guidance and mentorship to junior engineers and design staff.
• Manage multiple projects balancing priorities, timelines, and budgets.
• Prepare technical documentation and presentations for stakeholders.

Skills

Independent worker

Data analysis

Prioritization

Technical communication

Mentorship

Education

Bachelor's degree in Mechanical Engineering

Master's degree preferred

Tools

SolidWorks

Job description

engineeringjobs.net, Inc. is seeking a Principal/Senior Mechanical Engineer to lead design, development, and optimization of complex medical devices and combination products from concept through launch.

The role requires deep medical device expertise, strong product development and risk management skills, and the ability to mentor other engineers while delivering on schedule and budget in a fast-paced environment.