Principal/Senior 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

The Principal / Senior Mechanical Engineer will play a crucial role in the research and development team, focusing on the design, development, and optimization of complex medical devices, materials, and combination products from conception through launch.

Job requirements

Education & Qualifications:

• BS in Mechanical engineering (Masters Preferred)
• 8+ years of dedicated mechanical design experience, with at least 5 years specifically in the medical device industry
• Expert-level proficiency in CAD/solid modeling (Solidworks or equivalent)
• Strong knowledge of materials & fabrication/manufacturing/injection molding technologies
• Experience with FEA, CFD or other engineering simulation tools
• Deep mastery of medical device design controls and regulations (e.g. ISO 13485, ISO 14971, ISO 60601)
• Ability to work independently, analyse data rigorously, and manage multiple priorities.
• Excellent written and verbal communication skills.

Job responsibilities

• Lead the mechanical architecture and detailed design of complex, multi-component patient connected medical devices using CAD and simulation tools.
• Translate user needs into functional requirements and prototypes using advanced manufacturing techniques.
• Perform rigorous tolerance analysis (GD&T), structural/thermal FEA, and kinematic modeling to ensure absolute reliability in clinical environments.
• Architect and execute comprehensive Verification and Validation protocols within ISO 13485 and FDA 21 CFR Part 820 quality systems.
• Collaborate directly with manufacturing, quality, and supply chain teams to optimize designed for manufacturability (DFM), assembly (DFA), and cost at scale.
• Drive technical risk management (compliance with ISO 14971) through hazard analysis, fault tree analysis, FMEA, and rigorous root cause investigations.
• Provide technical guidance and mentorship to junior engineers and other design staff
• Manage multiple projects balancing technical priorities, timelines & budgets.
• Prepare technical documentation, reports and presentations for internal & external stakeholders.
• Competitive salary and benefits package
• Opportunities for professional development and career growth.
• Collaborative and innovative work environment.

Disclaimer:

The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.