Mechanical Engineer - Manufacturing Equipment
About The Position
Design and construct manufacturing equipment used to produce minimally invasive medical devices. The equipment ranges from custom manual fixtures to semi-automated electromechanical systems integrating workholding, sensing, motion, and vision control. The role contributes to developing manufacturing capabilities for minimally invasive surgery. The engineer applies mechanical engineering and design expertise while working with senior equipment staff and cross-functional departments to develop and sustain custom equipment for production. The position involves independently handling projects of medium to high complexity.
Requirements
- Bachelor of Science in Mechanical Engineering or Mechatronics Engineering, with a minimum of 4 years of related experience.
- Proficiency in 3D CAD; SolidWorks is preferred.
- Experience integrating mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.
- Strong understanding of tolerance analysis and statistical methods.
- Experience troubleshooting and repairing manufacturing equipment.
- Experience developing equipment qualification, calibration, and preventive maintenance procedures and practices.
- Self-motivated and able to work well with others in a team environment.
Nice To Haves
- Master of Science in Mechanical Engineering or equivalent, with a minimum of 4 years of prior experience.
- Prior experience developing and supporting catheter manufacturing equipment.
- Knowledge of equipment control systems and PLCs; Beckhoff is preferred.
- Prior experience with PLM systems (Agile preferred) and SAP applications, including ECO creation and origination of equipment specifications, test protocols, bills of materials, and work instructions.
- Structured problem-solving, rational thinking, and root-cause analysis capability.
- Experience working in medical-device or other regulated quality systems.
Responsibilities
- Design and build in-house manufacturing equipment from concept through implementation.
- Develop mechanical assembly design solutions, from simple fixtures to more complex automation equipment.
- Ensure equipment designs meet functional, safety, ergonomic, documentation, and validation requirements.
- Create and manage project plans, including schedules, budgets, and stakeholder updates.
- Develop equipment specifications, assembly instructions, maintenance procedures, and calibration procedures.
- Create and execute documentation and protocols for equipment DQ, IQ, OQ, and PQ validations.
- Conduct design reviews for new equipment throughout development.
- Provide equipment-related technical support for ongoing production operations and expansion.
- Establish and manage contractors, system integrators, and vendors for equipment project planning and execution.
- Support quality and internal and external audits as required.
- Support other equipment-related operations and duties as required.
Benefits
- Market-competitive compensation packages, including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
