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

United States of America Pay Ranges:

$89,300 - $148,800 USD Annual

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Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.