Primary Function of Position
Design and construct manufacturing equipment used to produce minimally invasive medical devices. This equipment will range in complexity from custom manual fixtures to semi-automated electro-mechanical systems, integrating work-holding, 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 autonomously 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.
• Iterate rapidly by prototyping, testing, and examining product designs using engineering methods and techniques, including computer simulation and physical models • 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 including duplication activities.
• Support other equipment-related operations and duties as required Qualifications Required Skills and Experience • Minimum BSME or similar.
• Minimum 3 years’ experience designing and developing Automated manufacturing equipment.
• Self-motivated, works well with others in a team environment.
• Proficiency with CAD (SolidWorks highly preferred): designing parts with complex geometry, creating assemblies and creating detailed manufacturing drawings • Comfortable operating machine shop, measurement, and test equipment • Mechanical design and exploration skills, including statics, dynamics, and strength of materials, including stress analysis, fatigue, and thermal • Experience in integration of mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.
• Experience troubleshooting and repair of manufacturing equipment.
• Experience developing equipment qualification, calibration and PM procedures and practices.
Required Education and Training
• Minimum BSME Mechanical or Mechatronics engineering with minimum of 5 years related experience.
• Experience with enterprise software (e.g. Agile document control, Confluence, Polarion, Windchill, etc) • Prior experience working with PLM systems (Agile preferred), SAP applications, including ECO creation, origination of equipment specification, test protocols, BOM, and work instructions.
Preferred Skills and Experience
• Excellent understanding of tolerance analysis and statistical methods. Fluency in ASME
Y14.5 GD&T and tolerance stack analysis
• MSME (or equivalent) with minimum 6 plus years prior experience.
• Structured Problem Solving. Rational thinking and root cause analysis capability.
• Experience working in a medical device or other regulated quality systems.
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