The Role
Leads mechanical architecture, design, simulation, verification, validation, and risk management for complex medical devices from conception through launch. Performs tolerance analysis, FEA, kinematic modeling, prototyping, and design-for-manufacturing optimization. Ensures compliance with medical device quality systems and regulations while collaborating with manufacturing, quality, and supply chain teams. Mentors junior engineers, manages multiple projects, and prepares technical documentation and presentations.
Summary Generated by Built In
The 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:
Job responsibilities
Benefits
Benefits:
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.
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.
Benefits
Benefits:
- 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.
Skills Required
- BS in Mechanical Engineering
- Master’s degree
- 8+ years of dedicated mechanical design experience
- At least 5 years of experience in the medical device industry
- Expert proficiency in CAD or solid modeling, such as SolidWorks
- Knowledge of materials, fabrication, manufacturing, and injection molding technologies
- Experience with FEA, CFD, or other engineering simulation tools
- 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
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The Company
What We Do
Therakos provides the THERAKOS® CELLEX® Photopheresis System for the palliative treatment of skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
