Senior Staff Engineer – Advanced Operations

About the role

Stryker Medical's Advanced Operations team brings new products into manufacturing. As a Senior Staff Engineer, you will lead process engineering during design transfer, equipment implementation and process development, partnering with engineering, quality, manufacturing and regulatory teams to support product launches in a regulated environment. The position is onsite.

Key responsibilities

• Lead process engineering for new product introductions, ensuring manufacturing readiness and compliance with design transfer requirements.
• Develop and implement manufacturing processes, methods and controls that meet quality, cost and schedule objectives.
• Create and support process risk assessments, control plans, manufacturing procedures and production validation for new launches.
• Evaluate, select, procure, install and validate manufacturing equipment and capital assets.
• Analyze process and equipment performance through testing, data collection, measurement system analysis and experimental studies.
• Develop inspection methods, test protocols and manufacturing controls to meet specifications and regulatory requirements.
• Mentor engineers and project teams and partner with R&D, Quality, Manufacturing, Regulatory Affairs, Marketing and Project Management teams.

Required profile

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 6 years of experience in process engineering, manufacturing engineering, advanced operations or a related field.
• Preferred: experience in an FDA-regulated or other highly regulated manufacturing environment.
• Preferred: experience reading engineering drawings, including GD&T.
• Preferred: certifications in Project Management, LEAN, Six Sigma, Operational Excellence or related.

Required skills

• Interpreting system drawings involving mechanical, electrical and software interactions.
• Process engineering and manufacturing controls.

What we offer

• Salary range of $102,600 - $171,000 USD annually.
• 20% travel.