Manufacturing Engineer
4 weeks ago
Primary Function of Position
Contribute your technical manufacturing and equipment design skills to a dynamic team creating endoscopes, capital equipment, accessories, and precision instruments for minimally invasive robotic-assisted surgery.
The role requires active participation in new product development teams, support the development/modification of software for test equipment to ensure comprehensive test coverage. Involves providing support for manufacturing lines, developing manufacturing equipment, and refining electro-mechanical components, assemblies, process documentation, tooling, and test methods. Additionally, it involves challenging product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical equipment.
Essential Job Duties
- Create, maintain, and improve “low to high-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
- Apply engineering concepts to the optimization of equipment and procedures to achieve better maintainability, reliability, capacity, and availability of equipment.
- Independently and proactively determines and analyzes trends for equipment performance
- Diagnose equipment breakdowns to define and implement improvement strategies.
- Resolve emergency and unscheduled problems/repairs of equipment.
- Design, document, procure, qualify, implement, and improve fixtures, tools, or equipment.
- Responsible for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA
- Orchestrates approach to determining root cause and problem solving on complex issues
- Conduct testing of software releases before deploying on manufacturing line
- Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
- Maintain compliance with medical device quality system including corrective action closure and Change Order implementation
- Conduct SAP transactions relevant to process or equipment operations.
- Provide technician training and oversee specified manufacturing stations to ensure quality.
- Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress
- Improve existing documentation for equipment installation, repair, and upkeep.
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