Process Development Engineer
2 weeks ago
As a Process Development Engineer, you will play a key role in determining and developing approaches to technical problems of moderate scope and complexity. Your primary focus will be on reducing product time to market while adhering to regulatory requirements, project deadlines, and product costs.
Main Responsibilities:
Provide engineering support for new product and process introductions, ensuring all activities are completed and documented in accordance with Stryker's new product development procedures.
Ensure the quality of processes and products as defined in operation and material specifications.
Select components and equipment based on analysis of specifications, reliability, and regulatory requirements.
Work with quality engineers to develop component-specific testing and inspection protocols.
Lead or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
Analyse equipment to establish operating data, conduct experimental tests, and result analysis.
Lead and/or participate in process review meetings.
Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches.
Complete capability studies for in-process inspection and generate subsequent inspection documentation.
Conduct MSA studies for new products and new processes.
Provide training for manufacturing team members.
Ensure adherence to GMP and safety procedures.
Review and approve validation documentation.
All other duties as assigned.
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