Process Development Engineer

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

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

Benefits

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.