Engineer, Advanced Operations (AO)

Stryker • Irvine, CA

8d • $79,900 - $127,500 • Onsite

About The Position

Join a team focused on bringing new medical device products from development into manufacturing. The Engineer for Advanced Operations supports process development, manufacturing readiness, and product transfer activities while working closely with engineering, quality, and operations teams. The role offers broad exposure to product launch activities, manufacturing process improvement, and regulated medical device environments.

The engineer develops and improves manufacturing processes, conducts process development and analysis, supports product transfers and launches, and designs manufacturing solutions. The position also involves technical documentation, manufacturing data analysis, troubleshooting, training technicians and operators, and presenting technical information to cross-functional teams.

Requirements

• Bachelor’s degree in Engineering or a related technical field, or an equivalent combination of education and experience.
• Proficiency with Microsoft Office Suite, especially Microsoft Word, Microsoft Excel, and Outlook.

Nice To Haves

• Two or more years of experience in medical device manufacturing, engineering, or a related highly regulated technical environment.
• Experience utilizing SolidWorks.
• Experience working within ISO standards, FDA regulations, design controls, and manufacturing scale-up activities.
• Experience reading and creating technical documentation and engineering records.
• Experience collecting, analyzing, and summarizing engineering or manufacturing data.

Responsibilities

• Develop, implement, and improve manufacturing processes to meet product specifications, quality standards, and production requirements.
• Execute process development activities, including Design of Experiments (DOE) and basic statistical analysis, to support process optimization and manufacturing readiness.
• Support product transfers from development to manufacturing while helping achieve project timelines, yield targets, and launch milestones.
• Design and implement tooling, equipment, test methods, and related manufacturing solutions while ensuring qualification requirements are met.
• Create and maintain technical documentation, including process procedures, product drawings, test protocols, validation plans, risk assessments, and engineering reports.
• Analyze manufacturing and product data to assess process capability, identify opportunities for improvement, and support quality objectives.
• Troubleshoot manufacturing process issues and provide technical support for new product introductions and existing operations.
• Train technicians and operators on manufacturing processes and present technical information during cross-functional project reviews and team meetings.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level