Medical Devices: Advanced Operations Engineer

Stryker; Irvine (CA); On-site; USD 80,000 - 128,000; Full time

Job summary

Stryker is seeking an Engineer for Advanced Operations in Irvine, CA, to help move medical device products from development into manufacturing. You will support process development, manufacturing readiness, and product transfer while collaborating with engineering, quality, and operations teams, with onsite work as the default.

The role offers exposure to product launches, process improvements, and regulated environments, including DOE design of experiments, statistical analysis, and

Qualifications

• Bachelor's degree in Engineering or related field.
• Proficiency with Microsoft Word, Excel, and Outlook.
• 2+ years in medical device manufacturing or regulated environment (preferred).
• Experience with SolidWorks; familiarity with ISO standards, FDA regulations, design controls, and scale-up.
• Ability to read and create technical documentation and analyze data.

Responsibilities

• Develop, implement, and improve manufacturing processes to meet specs and production requirements.
• Execute DOE and basic statistical analysis to support process optimization.
• Support product transfers from development to manufacturing and help meet timelines and launch milestones.
• Design and implement tooling, equipment, and testing methods while meeting qualifications.
• Create and maintain process documentation, drawings, test protocols, validation plans, risk assessments, and reports.
• Analyze data to assess process capability and support quality objectives.
• Troubleshoot manufacturing issues and support new product introductions and ongoing operations.
• Train technicians and operators and present technical information in cross-functional reviews.

Skills

DOE

Statistical analysis

Process development

Troubleshooting

Training

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Microsoft Office

Job description

Stryker is seeking an Engineer for Advanced Operations in Irvine, CA, to help move medical device products from development into manufacturing. You will support process development, manufacturing readiness, and product transfer while collaborating with engineering, quality, and operations teams, with onsite work as the default.

The role offers exposure to product launches, process improvements, and regulated environments, including DOE design of experiments, statistical analysis, and