Our Client, a Medical Devices/Healthcare company, is looking for a Manufacturing Engineer (Transfers) for their Parsippany, NJ location.
Responsibilities:
- Own and Review ECRs, ECNs, routers, BOM updates, and work instructions.
- Walk processes to assess readiness, risks, and implementation needs.
- Support equipment installation, qualification, validation, and decommissioning activities as needed at both the client sites and transfer supplier sites.
- Assist with protocol creation, execution support, and report activities tied to manufacturing changes and product transfers.
- Support transfer documentation forms.
- Use Windchill to review, manage, and support engineering documentation and change activity.
- Develop, review, and maintain SOPs to ensure manufacturing process consistency and compliance at various sites within the transfer scope.
- Maintain accuracy of controlled manufacturing records and related documentation.
- Partner with Transfer, Operations and Quality to improve flow, efficiency, and manufacturability.
Requirements:- Bachelor’s degree in Mechanical, Manufacturing, Industrial, or related engineering field.
- Experience in manufacturing engineering in a regulated production setting.
- Strong Windchill knowledge.
- Working knowledge of equipment qualification/validation processes and documentation.
- Experience with Gage R&R studies and interpretation.
- Strong control plan knowledge.
- Experience with controlled document maintenance.
- Experience with process changes, documentation, and cross-functional implementation.
Why Should You Apply?Why Should You Apply?