Job Description
Primary Function of Position
Design and construct manufacturing equipment used to produce minimally invasive medical devices. This manufacturing equipment will range in complexity from custom manual fixtures to semi-automated electro-mechanical systems, integrating workholding, sensing, motion and vision control. This position will play a critical role in developing cutting edge manufacturing capabilities to enable the future of minimally invasive surgery.
The ideal candidate should have a solid understanding of the technical aspects of mechanical engineering and design. He/she will work closely with senior level equipment staff and other departments to develop and sustain custom equipment for production use. This person will thrive working independently on projects with medium to high complexity.
Essential Job Duties
- Design and build in-house manufacturing equipment from concept to implementation.
- Create effective design solutions of mechanical assemblies from simple fixturing to more complex assembly for automation equipment.
- Ensure manufacturing equipment designs meet functional, safety, ergonomic, documentation, and validation requirements.
- Create and manage project plans including schedules, budgets, and stakeholder updates.
- Develop documentation for equipment including specifications, assembly instructions, maintenance, and calibration procedures.
- Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations.
- Conduct effective design reviews of new equipment at all stages of development.
- Provide equipment-related technical support for on-going production operation and expansion.
- Establish and manage external resources (contractors, system integrators, vendors) in the planning and execution of equipment projects.
- Support quality and internal/external audits as required
- Support other equipment-related operations and duties as required
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