Engineer, Advanced Operations (AO)

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Wellbeing program

Job summary

Stryker in Irvine, CA is seeking an Engineer for Advanced Operations to support process development, manufacturing readiness, and product transfer activities across engineering, quality, and operations. You will design and implement tooling and manufacturing solutions, conduct DOE and basic statistics, create technical docs, and train technicians while helping meet launch milestones and quality targets.

This role exposes you to regulated medical device environments and product launches across

Qualifications

• Bachelor's degree in Engineering or equivalent.
• Proficiency with MS Office (Word, Excel, Outlook).
• 2+ years in medical device manufacturing or regulated environment.
• Experience with ISO, FDA, design controls.
• Experience reading and creating engineering records.
• Experience collecting, analyzing, and summarizing data.
• Experience using SolidWorks.

Responsibilities

• Develop, implement, and improve manufacturing processes to meet product specs and quality standards.
• Execute DOE and basic statistical analysis to support optimization and readiness.
• Support product transfers from development to manufacturing and meet timelines.
• Design and implement tooling, equipment, and test methods with qualified processes.
• Create and maintain process procedures, drawings, test protocols, and validation plans.
• Analyze data to assess process capability and identify improvement opportunities.
• Troubleshoot process issues and support new product introductions.
• Train technicians and present technical information in cross-functional reviews.

Skills

Process development

Statistical analysis

Technical documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Microsoft Office

Job description

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.

Required Qualifications

What You Will Need

• 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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.