Engineer, Advanced Operations; AO

Position: Engineer, Advanced Operations (AO)
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 Solid Works 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.

Summary

Location:

Irvine, California Type:
Full time