Staff Project Engineer - Advanced Operations
$89,300–$148,800 year
Remote · Portage, Michigan, United States
Job Summary
Develop and validate manufacturing processes for new product introductions, transferring designs from concept through launch. Design and select equipment and process solutions based on product, quality, and regulatory requirements; execute IQ/OQ/PQ validations and help prepare validation documentation. Analyze process performance using data and statistical methods to improve capability and drive continuous improvement; apply structured problem-solving tools to optimize yield. Collaborate with R&D, Quality, Manufacturing, and Project Management to ensure successful product commercialization. Produce manufacturing documentation including PFMEA, Control Plans, SOPs, and PPAPs; support capital equipment projects from specification to installation and implementation. Train manufacturing teams and ensure smooth transition to production while maintaining GMP, safety, and regulatory compliance. Communicate project status, risks, and outcomes to stakeholders.
Required Qualifications
- Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related)
- 4+ years of experience in manufacturing, process development, or new product introduction
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