- Support the manufacture of orthopedic implants by performing manufacturing engineering, process improvement, and other technical functions which are necessary for the team to meet customer needs.
- 2+ years experience in a production/manufacturing environment
- Ensure proper and continuous operation of manufacturing equipment and systems.
- Provide technical upport for quality control, process improvement, cost savings, process development projects, new product launches, equipment qualifications, and process validations.
- Make proposals/recommendations in support of the team to help achieve team goals in quality, cost, delivery, safety, and morale.
- Should be able to draft, explain, and execute change control activities using Enterprise Change control systems.
- Able to interact and collaborate with multiple functions to ensure timely execution of changes.
- Periodically work independently with vendors.
- Investigate Quality issues for root cause, recommend/implement corrective action and document as needed.
- Maintain and troubleshoot equipment for cleaning, sealing, and Packaging, including sub-components like motors, valves, mechanical switches, PLC systems, and software as necessary.
- Make proposals/recommendations with regards to Capital equipment purchases, cost reduction opportunities, and Supplier/Vendor selection.
- Periodically lead projects and processes; work with cross-functional teams to get these project completed.
- Act as the point of contact with regards to new product development projects; participate in new product teams.
- Evaluate tool quality, perform PFMEA to analyze/determine Root Cause, and ensure Mistake Proofing.
- Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
- Demonstrated ability to prioritize and accomplish work with little supervision (self-starter)
- Demonstrated ability to perform in and be challenged by a team-based environment, which places a high degree of emphasis on accountability for customer service levels, inventory management, cost reduction and quality/GMP compliance
- Experience owning Nonconformances or CAPAs.
- Experience within a Good Manufacturing Practices (GMP) controlled environment.
- Experience in mitigating the possibility of Human Errors in manufacturing.
- Familiar with reading blueprints and associated Geometric Dimensioning and Tolerancing (GD&T).
- Experience with any (or all) of the following systems would be preferred : Windchill, Trackwise, Oracle 11i, ValGenesis, ProEngineer, Master CAM.
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