Senior Manufacturing Engineer, Packaging

Stryker; Irvine (CA); On-site; USD 89,000 - 149,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Tobacco cessation program

Job summary

Stryker Irvine, CA is seeking an engineer to support manufacturing operations, design and validate equipment, and collaborate with cross‑functional teams to optimize processes. The role requires a Bachelor's degree in Engineering and 2+ years of manufacturing experience, with proficiency in reading engineering drawings.

Join a team focused on patient safety, product quality, and regulatory compliance while contributing to ongoing product development and sustaining engineering activities.

Qualifications

• Bachelor's degree in Engineering.
• 2+ years of relevant experience supporting manufacturing processes and operations in a production environment.
• Experience conducting process, equipment, or product qualification, verification, and validation activities.
• Experience troubleshooting manufacturing, process, or quality-related issues and implementing effective solutions.
• Experience designing, developing, or supporting manufacturing equipment, tooling, and fixtures.
• Ability to create, read, and interpret engineering drawings using standard engineering software.
• Strong analytical and problem-solving skills, including statistical, geometric, and mathematical analysis.
• Ability to manage technical responsibilities with limited supervision.

Responsibilities

• Support packaging work center with production challenges, manage change orders, and coordinate with cross functional teams with disposition of materials, sub-assemblies, and Finished Goods.
• Train operators on new revisions of documents released through change order management process.
• Execute validation activities for new equipment.
• Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost.
• Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements.
• Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
• Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting.
• Participate in risk management and design control activities, including FMEA and design reviews.
• Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance.
• Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation.
• Evaluate and implement process or product alternatives to optimize manufacturing performance.
• Collaborate with suppliers and external partners to support equipment, process, and product initiatives.
• Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.

Education

Bachelor's degree in Engineering

Job description

• Support packaging work center with production challenges, manage change orders, and coordinate with cross functional teams with disposition of materials, sub-assemblies, and Finished Goods.
• Train operators on new revisions of documents released through change order management process.
• Execute validation activities for new equipment.
• Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost.
• Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements.
• Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
• Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting.
• Participate in risk management and design control activities, including FMEA and design reviews.
• Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance.
• Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation.
• Evaluate and implement process or product alternatives to optimize manufacturing performance.
• Collaborate with suppliers and external partners to support equipment, process, and product initiatives.
• Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.
  

What You Will Do

• Support packaging work center with production challenges, manage change orders, and coordinate with cross functional teams with disposition of materials, sub-assemblies, and Finished Goods.
• Train operators on new revisions of documents released through change order management process.
• Execute validation activities for new equipment.
• Analyze, troubleshoot, and resolve manufacturing issues impacting product quality, safety, delivery, or cost.
• Design, develop, and implement manufacturing equipment, tooling, and fixtures to support production requirements.
• Design and coordinate engineering tests and experiments; analyze data, draw conclusions, and communicate recommendations.
• Support product development and sustaining engineering activities through technology development, specification creation, process studies, material testing, and technical reporting.
• Participate in risk management and design control activities, including FMEA and design reviews.
• Partner with operators, technicians, production supervisors, quality engineers, and cross-functional teams to address production floor challenges and improve manufacturing performance.
• Manage engineering project activities including planning, documentation, scheduling, progress tracking, and implementation.
• Evaluate and implement process or product alternatives to optimize manufacturing performance.
• Collaborate with suppliers and external partners to support equipment, process, and product initiatives.
• Champion patient safety, product quality, and compliance with Stryker's Quality Management System and applicable regulatory requirements.
  

What You Need

Required Qualifications

• Bachelor's degree in Engineering.
• 2+ years of relevant experience supporting manufacturing processes and operations in a production environment.
• Experience conducting process, equipment, or product qualification, verification, and validation activities.
• Experience troubleshooting manufacturing, process, or quality-related issues and implementing effective solutions.
• Experience designing, developing, or supporting manufacturing equipment, tooling, and fixtures.
• Ability to create, read, and interpret engineering drawings using standard engineering software.
• Strong analytical and problem-solving skills, including statistical, geometric, and mathematical analysis.
• Ability to manage technical responsibilities with limited supervision.
  

Preferred Qualifications

• Experience within the medical device industry or another regulated manufacturing environment.
• Proficiency with Minitab or similar statistical software.
• Experience participating in design control activities, including risk analysis and FMEA.
• Experience selecting suppliers and assessing supplier capabilities and performance.
• Experience supporting materials testing, process studies, and manufacturing investigations.
  

$89,400 - $148,900 USD Annual
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.