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Sr. Manufacturing Engineer
4 months ago
Primary Function of Position:
The successful candidate:
- Support the development/modification of software for test equipment to ensure comprehensive test coverage.
- 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.
- Autonomously and proactively resolves and evaluates 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.
- Accountable for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA
- Orchestrates approach to establishing 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 personal priorities 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.
- Contributes to the successful support and advancement of mid-volume manufacturing for stapler instruments for minimally invasive robotic surgery.
- Applicant in this role must demonstrate proven design for manufacturability and mechanical design capabilities to deliver consistent improvements for production of stapler instruments.
- Applicant in this role will provide daily support for day-to-day manufacturing operations and process/mechanical design improvements for existing stapling instruments.
- The role requires effective participation in sustaining product development teams that create and refine components, assemblies, process documentation, tooling, and test methods while challenging product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments and accessories.
- This position will focus on meeting manufacturing operations and product safety, reliability, and performance goals.
Position Roles and Responsibilities:
Specific responsibilities for this Manufacturing Engineer position include:
- Provide technical support and failure analysis, for discrepant production components and assemblies.
- Develop, maintain, and improve manufacturing processes using pFMEA as a guide.
- Provide leadership and mentorship to team members as needed.
- Design, build, document and/or specify manufacturing assembly fixtures.
- Establish and perform IQ/OQ/PQ on equipment and fixtures. As well as execute validations on Manufacturing lines (PPQ).
- Support Design Verification and Validation (V&V) activities.
- Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.
- Assist supplier engineers with material procurement issues.
- Support quality system compliance including discrepant material dispositions, ECO implementation, and nonconforming evaluations.
- Accountable for supporting Corrective and Preventive Action projects and resolving quality notifications.
Preferred Skills and Experience
- Experience with C#, Python, .NET WPF application.
- Familiarity with databases (SQL, etc.)
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
- Prior experience with complex device manufacturing is a plus.
- Previous experience with ERP systems (preferred SAP) is a plus.
