Senior Mechanical Engineer

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

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.