Engineer, Advanced Operations (AO)

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

Work Flexibility: Onsite Join a team focused on bringing new medical device products from development into manufacturing. As a Engineer for Advanced Operations, you will support process development, manufacturing readiness, and product transfer activities while working closely with engineering, quality, and operations teams. This role offers broad exposure to product launch activities, manufacturing process improvement, and regulated medical device environments.

What You Will Do

• 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 You Will Need

Required Qualifications

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

Preferred Qualifications

• 2 or more years 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.

$79,900 - $127,500 USD Annual Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.