Manufacturing Engineer
Manufacturing Engineer
Posted on :
04-11-2024
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Job Description
Job Code: INT30327
Job ID: 497509
Role: Manufacturing Engineer
Location: Reedsville PA Onsite
Description:
- Expert on manufacturing process flow and design transfer Lead manufacturing fixture development process development and qualifications lead process development and optimization of critical fabrication
- Maintain manufacturing specifications requirements and Failure Modes and Effects Analyses (FEMA) in accordance with protocols and FDA guidance documents
- Expert technical lead on design transfer in partnership with contract manufacturers conduct and lead failure investigations ensure document management and manufacturing control compliance.
- Conduct and manage structured design reviews. works with hardware software and firmware engineers user experience specialists and system engineers
- Guide and participate in test method validation risk assessment requirement development protocol and validation report writing.
- Maintain Validate and Release Test Systems in Production Environment ideally in FDA regulated business.
- Firm understanding of IQ OQ PQ and Software Validation requirements and practices.
- Expertise in PFMEA Gage R&R test system and manufacturing software validation for medical devices within the manufacturing environment.
- Ability to learn and adapt to QMS and work closely with Philips Engineering community on new validation methods and revalidation projects.
- Guide and participate in bug testing identification and problem solving
Qualification:
- BS/BA degree in Management Operations Engineering or closely related field
Employment Type
Full Time
Key Skills
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