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Skills: Process Development, Medical Device Manufacturing, Design of Experiments, Statistical Analysis, Process Validation
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$18/hr–$23/hr
Mid level
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$103k–$171k/yr
Full-time
bachelor degree
Posted 43d ago
~40 hrs/week
Responsibilities
Lead the development and industrialization of manufacturing processes for new medical devices at external supplier sites. Coordinate validation activities, process characterization, and technical reviews to ensure successful product launches.
Requirements
Requires a Bachelor's degree in an engineering discipline and at least 5 years of experience in the medical device industry. Candidates must have proven expertise in process validation, statistical analysis, and working with contract manufacturers.
Full job description
Work Flexibility: Onsite
Join a team focused on bringing innovative medical devices from concept into commercial production through strong manufacturing execution and supplier collaboration. In this role, you will work closely with contract manufacturers, component suppliers, and cross-functional teams to develop, validate, and industrialize manufacturing processes that support successful product launches. This position offers the opportunity to lead technical activities across the product development lifecycle while driving manufacturing readiness at external production partners.
What You Will Do
Leaddevelopment of manufacturing processes at external suppliers for new product introduction programs, from concept through commercial launch.
Design and executeprocess characterization studies, Design of Experiments (DOE), and statistical analyses to establish process capability, critical parameters, and operating windows.
Develop and coordinatemanufacturing industrialization plans, including engineering builds, validation activities, readiness reviews, and commercialization milestones.
Drivesupplier technical execution by leading technical reviews, monitoring engineering deliverables and schedules, and resolving manufacturing and process-related issues.
Create and maintainvalidation and manufacturing documentation, including IQ/OQ/PQ protocols, validation reports, process flows, equipment specifications, work instructions, and risk assessments.
What You Will Need
Required:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
Minimum 5 years of engineering experience within the medical device industry.
Experience developing manufacturing processes for new products.
Experience working directly with external suppliers or contract manufacturers.
Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ).
Preferred:
Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products.
Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging.
Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP.
United States of America Pay Ranges:
US15: $102,700 - $171,100 USD Annual
Travel Percentage: 20%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.
Related keywords
Medical DevicesProcess DevelopmentManufacturing EngineeringSupplier CollaborationDesign of ExperimentsDOEStatistical AnalysisProcess CharacterizationIQ/OQ/PQValidationIndustrializationEngineering BuildsPFMEAAPQPPPAPMinitab
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 9 consecutive years as one a World's Best Workplace
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How many Healthcare jobs are open in Irvine, CA right now?
There are currently 1,134 open healthcare positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Irvine, CA?
Companies currently hiring include UCI Health, Edwards Lifesciences, City of Hope, Allergan, Hoag Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Irvine, CA?
Yes — 201 of the 1134 open healthcare positions offer remote or hybrid work (69 remote, 132 hybrid).
How do I apply for Healthcare jobs in Irvine, CA?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.