Process Development Engineer

Responsibilities

• Perform characterization studies with statistical analysis and create test reports. Process Development and Validation experience is a must.
• Write process instructions, manufacturing operating procedures, and PFMEAs and build equipment and set up manufacturing line(s).
• Process and run engineering Wos.
• Travel within USA and Mexico if required to write and execute IQOQPQ.
• Write and stage CRs and CNs in Windchill.
• Lead and drive execution of design for manufacturing, including component manufacturing within DMAIC principles; develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions.
• Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders.
• Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc.
• Actively coordinate and mitigate delays within project and tasks; collaborate with cross-functional teams (engineering, manufacturing, marketing, suppliers).
• Release comments : EIS – Medical Device & Regulations; EIS – NPD Methodology and Management.

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