Process Development Engineer

Stryker; Irvine (CA); On-site; USD 103,000 - 171,000; Full time

Job summary

Stryker in Irvine is seeking a seasoned Manufacturing Engineer to lead the development of manufacturing processes at external suppliers for new product introductions, from concept through commercial launch.

You will design and execute process characterization studies, DOE, and statistical analyses to establish process capability, critical parameters, and operating windows. The role also involves coordinating industrialization plans and documentation.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical or Manufacturing Engineering or related field.
• Minimum 5 years in the medical device industry.
• Experience developing manufacturing processes for new products.
• Experience with external suppliers or contract manufacturers.
• Experience with process characterization, DOE, statistics, and IQ/OQ/PQ validation.

Responsibilities

• Lead development of manufacturing processes at external suppliers for new product introductions from concept to launch.
• Design and execute process characterization studies, DOE, and statistical analyses to establish capability and operating windows.
• Develop and coordinate manufacturing industrialization plans, validation activities, readiness reviews, and milestones.
• Drive supplier technical execution by leading reviews, monitoring deliverables, and resolving issues.
• Create and maintain validation and manufacturing documentation (IQ/OQ/PQ, reports, processes, specs, work instructions, risk assessments).

Skills

Process development

DOE

Statistical analysis

Supplier management

IQ/OQ/PQ

DOE optimization

Education

Bachelor's in Mechanical/ Biomedical/ Manufacturing Engineering

Tools

Minitab

JMP

Job description

Work Flexibility: Onsite

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.