Principal Medical Device Mechanical Engineer

Therakos Healthcare Limited; Nashville (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

Therakos Healthcare Limited in Nashville, TN, is seeking a Principal/Senior Mechanical Engineer to drive the design, development, and optimization of complex medical devices and combination products from concept through launch.

You will lead mechanical architecture, oversee design controls per ISO 13485 and ISO 14971, mentor engineers, and collaborate with manufacturing and quality to ensure manufacturability and patient safety in fast-paced projects.

Qualifications

• BS in Mechanical Engineering; masters preferred.
• 8+ years of mechanical design experience; 5+ in medical devices.
• Expert-level CAD/solid modeling (SolidWorks or equivalent).
• Knowledge of materials and fabrication/manufacturing/injection molding.
• Experience with FEA/CFD or engineering simulation tools.
• Medical device design controls and regulations (ISO 13485, 14971, 60601).
• Independent work, rigorous data analysis, multitasking, strong communication.

Responsibilities

• Lead mechanical architecture and detailed design of complex patient-connected devices using CAD and simulations.
• Translate user needs into functional requirements and prototypes via advanced manufacturing.
• Perform GD&T tolerance analysis, structural/thermal FEA, and kinematic modeling for reliability.
• Architect and execute Verification and Validation per ISO 13485 and FDA 21 CFR 820.
• Collaborate with manufacturing, quality, and supply chain to optimize DFM/DFA and cost.
• Drive ISO 14971 risk management with 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, reports and presentations for stakeholders.

Skills

Mechanical design

CAD (SolidWorks)

FEA/CFD tools

Design controls

Communication skills

Education

BS in Mechanical Engineering

Tools

SolidWorks

Job description

Therakos Healthcare Limited in Nashville, TN, is seeking a Principal/Senior Mechanical Engineer to drive the design, development, and optimization of complex medical devices and combination products from concept through launch.

You will lead mechanical architecture, oversee design controls per ISO 13485 and ISO 14971, mentor engineers, and collaborate with manufacturing and quality to ensure manufacturability and patient safety in fast-paced projects.