Senior Manufacturing Engineer

Stryker; Cary (IL); On-site; USD 86,000 - 143,000; Full time

Benefits offered by this job

Health benefits

HSA (Health Savings Account)

FSAs (Flexible Spending Accounts)

401(k) plan

Employee Stock Purchase Plan (ESPP)

Life and AD&D insurance

Short-term disability insurance

Wellbeing program

Job summary

Stryker in Cary, IL is seeking a manufacturing engineering professional to lead process improvements, support automation systems, and validate new equipment in a highly automated GMP production environment.

You will develop FMEAs, control plans, IQ/OQ/PQ, write SOPs, monitor line performance, and drive reliability and quality through structured problem solving.

Qualifications

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 2 years of full-time experience in manufacturing engineering or related discipline.
• Experience supporting manufacturing operations and production equipment.
• Experience troubleshooting automated manufacturing equipment.
• Experience implementing process improvements in manufacturing.

Responsibilities

• Support FAT, equipment installation, commissioning, and startup activities.
• Develop and maintain FMEAs, control plans, and process documentation.
• Execute process validation activities (IQ/OQ/PQ) and Validation Plans.
• Create SOPs and GMP-compliant technical documentation.
• Monitor line performance, troubleshoot issues, and drive reliability and quality.

Skills

Automation systems

Troubleshooting automated equipment

Process improvement

GMP SOP documentation

Education

Bachelor’s degree in Engineering

Preferred: Mechanical / Electrical / Controls / Industrial / Biomedical / Manufacturing Engineering

Job description

Join a manufacturing engineering team that supports the production of medical device, drug, and cosmetic products in a highly automated, regulated manufacturing environment. This role provides technical leadership for manufacturing processes and equipment, with a focus on supporting automation systems, validating new equipment, and driving operational performance in a world-class production facility.

What You Will Do

• Support factory acceptance testing (FAT), equipment installation, commissioning, and startup activities for new manufacturing equipment and automation systems.
• Develop and maintain process Failure Mode and Effects Analyses (FMEAs), control plans, and other process documentation for new and existing production lines.
• Execute and document process validation activities, including Validation Plans (VP), User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Create and maintain standard operating procedures (SOPs), work instructions, and technical documentation in compliance with Good Manufacturing Practices (GMP).
• Monitor production line performance, investigate equipment and process issues, and lead structured problem-solving initiatives to improve reliability, efficiency, and quality.

What You Will Need

Required:

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 2 years of full-time experience in manufacturing engineering, mechanical engineering, or a related engineering discipline.
• Minimum 2 years of experience supporting manufacturing operations and production equipment.
• Experience troubleshooting automated manufacturing equipment.
• Experience implementing process improvements in a manufacturing environment.

Preferred:

• Bachelor’s degree in Mechanical, Electrical, Controls, Industrial, Biomedical, or Manufacturing Engineering.
• Minimum 2 years of experience in the medical device industry.
• Experience writing, executing, and documenting process or equipment validations, including IQ, OQ, PQ, or related protocols.

United States of America Pay Ranges:

$85,500 - $142,500 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.