Fda 21 Cfr Part 820 Engineer Jobs

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Today

Principal/Senior Mechanical Engineer

Therakos Franklin, TN

Franklin, TN

Today

Full time Senior Design Design Engineering

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Job Description

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

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