Medical Device Process Development Lead

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

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan

Short-term disability

Job summary

Stryker in Irvine, CA seeks an experienced manufacturing process engineer to lead development with external suppliers from concept to launch. You will design studies, establish process capability, and drive validation activities for new medical device products.

Responsibilities include coordinating industrialization plans, validating processes, and maintaining comprehensive documentation across IQ/OQ/PQ, process flows, and specs.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering or related field.
• 5+ years of engineering experience in the medical device industry.
• Experience developing manufacturing processes for new products.
• Experience with external suppliers/contract manufacturers.
• Experience with DOE, statistical analysis, and IQ/OQ/PQ validation.

Responsibilities

• Lead development of manufacturing processes at external suppliers from concept through launch.
• Design and execute process characterization studies and DOE to establish process capability and operating windows.
• Develop manufacturing industrialization plans including validation, readiness reviews, and milestones.
• Drive supplier technical execution, lead technical reviews, monitor deliverables and schedules.
• Create and maintain validation and manufacturing documentation (IQ/OQ/PQ, reports, process flows, specs, work instructions, risk assessments).

Skills

Process development

DOE

Statistical analysis

IQ/OQ/PQ

External suppliers

Manufacturing readiness

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Manufacturing Engineering

Tools

Minitab

JMP

Job description

Stryker in Irvine, CA seeks an experienced manufacturing process engineer to lead development with external suppliers from concept to launch. You will design studies, establish process capability, and drive validation activities for new medical device products.

Responsibilities include coordinating industrialization plans, validating processes, and maintaining comprehensive documentation across IQ/OQ/PQ, process flows, and specs.