Senior Mechanical Engineer - Medical Devices, R&D & DFM

Therakos Healthcare Limited; Nashville (TN); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Competitive salary and benefits

Job summary

Therakos Healthcare Limited seeks a Principal/Senior Mechanical Engineer to lead the design, development, and optimization of complex medical devices and combination products from concept through launch.

The role requires 8+ years of mechanical design experience, including 5+ in the medical device industry, and strong CAD/FEA skills. You will work with manufacturing, quality, and supply chain teams to ensure manufacturability and regulatory compliance.

Qualifications

• BS in Mechanical engineering; Masters preferred.
• 8+ years mechanical design experience, 5+ in medical devices.
• Expert CAD/solid modeling with SolidWorks or equivalent.

Responsibilities

• Lead mechanical architecture and detailed design of complex medical devices.
• Translate user needs into functional requirements and prototypes using advanced manufacturing.
• Perform tolerance analysis (GD&T), FEA/CFD, ensuring reliability in clinical environments.
• Execute Verification/Validation protocols within ISO 13485 and FDA 21 CFR Part 820.
• Collaborate with manufacturing, quality, and supply chain to optimize DFM/DFA and cost.
• Drive risk management per ISO 14971 with hazard analysis and FMEA.
• Provide mentorship to junior engineers and manage multiple projects.
• Prepare technical docs and presentations for stakeholders.

Skills

CAD/solid modeling

FEA/CFD

Regulatory know-how ISO 13485/14971//I

DFM/DFA

Communication

Education

BS in Mechanical Engineering

Masters preferred

Tools

SolidWorks

Job description

Therakos Healthcare Limited seeks a Principal/Senior Mechanical Engineer to lead the design, development, and optimization of complex medical devices and combination products from concept through launch.

The role requires 8+ years of mechanical design experience, including 5+ in the medical device industry, and strong CAD/FEA skills. You will work with manufacturing, quality, and supply chain teams to ensure manufacturability and regulatory compliance.