Process Development Engineer

Roles & Responsibilities :

• Under limited supervision and in accordance with all applicable federal, state and local laws, regulations and procedures and guidelines, the duties and responsibilities for this position are.
• Must be able to perform characterization studies with statistical analysis and create test reports Process Development and Validation Experience is a must.
• Must write process instructions, manufacturing operating procedures, and PFMEAs Must build equipment and setup manufacturing line(s).
• Process and run engineering Wos.
• Able to travel within USA and Mexico if required to write and execute IQOQPQ.
• Must be able to write and stage CRs CNs in Windchill Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC 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 team, work with engineering, manufacturing, marketing and suppliers.
• Release Comments : EIS : Medical Device & Regulations EIS : New Product Development (NPD) Methodology and Management.