Process Development Engineer

Posted 5 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
103K-171K Annually
Senior level
Healthtech • Other • Robotics • Biotech • Manufacturing
Together with our customers, we're on a mission to make healthcare better.
The Role
Develops, validates, and industrializes medical device manufacturing processes at external suppliers from concept through commercial launch. Leads process characterization, DOE, statistical analysis, engineering builds, validation, readiness reviews, and commercialization milestones. Coordinates supplier technical execution, resolves manufacturing issues, and maintains validation and manufacturing documentation, including IQ/OQ/PQ protocols, reports, process flows, equipment specifications, work instructions, and risk assessments.
Summary Generated by Built In
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

  • Lead development of manufacturing processes at external suppliers for new product introduction programs, from concept through commercial launch.

  • Design and execute process characterization studies, Design of Experiments (DOE), and statistical analyses to establish process capability, critical parameters, and operating windows.

  • Develop and coordinate manufacturing industrialization plans, including engineering builds, validation activities, readiness reviews, and commercialization milestones.

  • Drive supplier technical execution by leading technical reviews, monitoring engineering deliverables and schedules, and resolving manufacturing and process-related issues.

  • Create and maintain validation 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.

Skills Required

  • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline
  • At least 5 years of engineering experience in 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, statistical analysis, and manufacturing process validation using IQ/OQ/PQ
  • Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products
  • Experience with extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging
  • Experience with manufacturing industrialization, technology transfer, Design for Manufacturability, PFMEA, APQP, PPAP, Minitab, or JMP

Stryker Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.

  • Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
  • Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
  • Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.

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The Company
HQ: Portage, MI
51,000 Employees
Year Founded: 1941

What We Do

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.

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