Staff 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.

Key Responsibilities:

• 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

Minimum Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related)

• 4+ years of experience in manufacturing, process development, or new product introduction

Preferred Qualifications:

• Experience in regulated industries (medical device, pharma, automotive, etc.)

• Experience with process validation, statistical analysis, and manufacturing technologies

• Lean/Six Sigma experience