Process Development Engineer
Stryker
Process Development Engineer
Job Description
Work Flexibility: OnsiteJoin 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 DoLead 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 NeedRequired: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.
Locations
- California, Irvine
Salary
102,700 - 171,100 USD / yearly
Skills Required
- process characterizationintermediate
- manufacturing technologies such as extrusionintermediate
- manufacturing industrializationintermediate
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline. (degree in mechanical engineering)
- Minimum 5 years of engineering experience within the medical device industry. (experience, 5 years)
- Experience developing manufacturing processes for new products. (experience)
- Experience working directly with external suppliers or contract manufacturers. (experience)
- Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ). (experience)
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline. (degree in mechanical engineering)
- Minimum 5 years of engineering experience within the medical device industry. (experience, 5 years)
- Experience developing manufacturing processes for new products. (experience)
- Experience working directly with external suppliers or contract manufacturers. (experience)
- Experience with process characterization, Design of Experiments (DOE), statistical analysis, and manufacturing process validation (IQ/OQ/PQ). (experience)
Preferred Qualifications
- Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products. (experience)
- Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging. (experience)
- Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP. (experience)
- Experience supporting catheter-based, minimally invasive, electromechanical, or similar medical device products. (experience)
- Experience with manufacturing technologies such as extrusion, laser processing, thermal bonding, braiding, injection molding, machining, automated assembly, or packaging. (experience)
- Experience with manufacturing industrialization, technology transfer, Design for Manufacturability (DFM), PFMEA, APQP, PPAP, Minitab, or JMP. (experience)
Responsibilities
- 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.
- 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.
Benefits
- general: US15: $102,700 - $171,100 USD Annual
Tags & Categories
Answer 10 quick questions to check your fit for Process Development Engineer @ Stryker.
10 Questions
~2 Minutes
Instant Score