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Manufacturing Engineer

2 months ago

Mahwah, United States Comrise Full time

Manufacturing Engineer- TOP medical device company- long term contract


• Create and manage Engineering Change Requests as well as product impact assessments.

• Manage Engineering Change Notices for process changes from creation to final approval

• Demonstrate a general understanding of Product Part Approval Process (PPAP)

• Demonstrate a general understanding of First Article Inspection (FAI) process

• Periodically lead projects and processes; work with cross-functional teams to get these projects completed.

• Ability to multi-task between different projects and changes.

• Investigate Quality issues for root cause and recommend/implement corrective actions.

• Ability to oversee team members' workload and provide support when issues arise.

• Work to support team members as both mentor/mentee when necessary.


• Education and Special Training Required: Bachelor’s Degree in Engineering or relevant field of study Qualifications and Work Experience Required

• 1-3 years’ experience in a production/manufacturing environment.

• Demonstrated computer skills using Microsoft Office applications (Word, Excel, PowerPoint, Project, etc), and experienced work in a Quality Management System

• Demonstrated interpersonal, communication and presentation skills. Must be comfortable presenting at team level meetings and lead meetings as necessary.

• Demonstrate strong teamwork and time management skills as well as be able to operate in a fast-paced environment.

• Ability to perform in and be challenged by a multi-disciplinary team-based environment, which places a high degree of emphasis on accountability for quality/GMP/GDP compliance.

• Provide technical support for quality control, process improvement, equipment qualifications, and process validations.

• Operate within Stryker’s quality management system (QMS) to produce and/or review documentation such as, inspection guide sheets, product drawings, dynamic control plans (DCPs), and standard operating procedures (SOPs)