Onsite Process Development Engineer - Medical Devices

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

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.