Principal/Senior Mechanical Engineer

Therakos is seeking a Principal/Senior Mechanical Engineer to lead end-to-end mechanical design and optimization of complex, patient-connected medical devices through launch.

Responsibilities

• Own mechanical architecture and detailed design for complex, multi-component patient connected medical devices using CAD and simulation tools.
• Convert user needs into functional requirements, prototypes, and design directions using advanced manufacturing approaches.
• Run rigorous engineering analyses including tolerance analysis (GD&T), structural/thermal FEA, and kinematic modeling to support reliable performance in clinical environments.
• Architect and execute Verification and Validation plans aligned to ISO 13485 and FDA 21 CFR Part 820 quality systems.
• Partner with manufacturing, quality, and supply chain teams to improve manufacturability using DFM, DFA, and cost optimization for scale.
• Lead technical risk management in accordance with ISO 14971 through hazard analysis, fault tree analysis, FMEA, and root cause investigations.
• Provide technical direction and mentorship to junior engineers and other members of the design organization.
• Manage multiple concurrent projects by balancing technical priorities with timelines and budgets.
• Develop and maintain technical documentation, reports, and presentations for internal and external stakeholders.

Requirements

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

Technologies

• Solidworks
• CAD / solid modeling
• FEA
• CFD

Benefits

• 401(k)
• Dental insurance
• Employee assistance program
• Retirement plan

Work Location

• Franklin, TN (onsite)
• In person