Manufacturing Engineer - Katalyst Healthcares and Life Sciences : Job Details
Manufacturing Engineer
Katalyst Healthcares and Life SciencesJob Location : Reedsville,PA, USA
Posted on :
2025-02-05T07:42:14Z
Job Description :
Responsibilities:
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- 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.
- BS/BA degree in Management, Operations, Engineering or a closely related field.
- 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 Philips QMS and work closely with the Philips Engineering community on new validation methods and re-validation projects.
- Guide and participate in bug testing, identification, and problem-solving.
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