Project Engineer - Advanced Operations

Position Summary

You will play a key role in bringing new products from concept through commercialization by developing and validating manufacturing processes. This role partners cross-functionally to ensure high-quality, efficient, and compliant product launches.

• Develop and implement manufacturing processes to support new product introductions from design transfer through launch
• Design and select equipment and process solutions based on product, quality, and regulatory requirements
• Execute process validations (IQ, OQ, PQ) and support development of validation documentation
• Analyze process performance using data, experiments, and statistical methods to improve capability and resolve issues
• Apply structured problem-solving tools to establish parameters, improve yield, and drive continuous improvement
• Partner with R&D, Quality, Manufacturing, and Project Management to ensure successful product commercialization
• Develop manufacturing documentation including PFMEA, Control Plans, SOPs, and PPAPs
• Support capital equipment projects
  , including specification, installation, and implementation
• Train manufacturing teams and ensure smooth transition to production
• Ensure compliance with GMP, safety, and regulatory requirements
• Communicate project status, risks, and outcomes to stakeholders

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related)
• 4+ years of experience in manufacturing, process development, or new product introduction

• Experience in regulated industries (medical device, pharma, automotive, etc.)
• Experience with process validation, statistical analysis, and manufacturing technologies
• Lean/Six Sigma experience

$89,300 - $148,800 USD Annual