What are the responsibilities and job description for the Manufacturing Engineer position at TekOne IT Services Pvt. Ltd.?
Hello,
Have an opportunity for Manufacturing Engineer @ Reedsville, PA (Onsite) - Contract 12 Months, If availbale and interested, please do sahre updated resume to vineeth@intellectt.com or can reach out on 732-934-4269. Thanks !!!
MANUFACTURING ENGINEER
REEDSVILLE, PA (ONSITE)
12 Months Contract
Have an opportunity for Manufacturing Engineer @ Reedsville, PA (Onsite) - Contract 12 Months, If availbale and interested, please do sahre updated resume to vineeth@intellectt.com or can reach out on 732-934-4269. Thanks !!!
MANUFACTURING ENGINEER
REEDSVILLE, PA (ONSITE)
12 Months Contract
- 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 Philips QMS and work closely with Philips Engineering community on new validation methods and re-validation projects.
- Guide and participate in bug testing, identification, and problem solving
- BS/BA degree in Management, Operations, Engineering or closely related field
