Senior Process Engineer, Advanced Operations (AO)

Stryker; Portage (MI); On-site; USD 78,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Stock Purchase Plan (ESPP)

Dental insurance

Vision insurance

Wellbeing program

Job summary

Stryker's Advanced Operations (AO) team is seeking a Process Engineer to drive successful product introductions and manufacturing readiness in a regulated environment. You will lead process design, validation, and equipment qualification while collaborating with cross-functional teams to deliver scalable, compliant manufacturing solutions.

Responsibilities include developing manufacturing processes, performing PFMEA, Control Plans, SOPs, PPAP, MSA, and verification testing.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field is required.
• Experience with manufacturing processes, materials, product or process design is preferred.
• Ability to read and interpret engineering drawings and specifications.

Responsibilities

• Lead process engineering activities for new product introductions and transfers.
• Develop and implement manufacturing processes meeting specs and GMP/regulatory requirements.
• Plan and execute process validation, PFMEA, Control Plans, SOPs, PPAP, MSA.
• Lead capital equipment qualification, vendor coordination, and installation.
• Analyze process performance and drive continuous improvement for readiness.
• Train manufacturing personnel and support product launches and scale-up.

Skills

Reading drawings

Statistical analysis

Process validation

DFM knowledge

Education

Bachelor's degree in Mechanical Engineering

Job description

Join Stryker's Advanced Operations (AO) team and play a key role in supporting the successful introduction of new products and manufacturing processes. In this role, you will provide process engineering expertise across product launches, transfers, equipment validation, and manufacturing readiness while ensuring compliance with quality and regulatory requirements. This position offers the opportunity to collaborate with cross-functional teams to develop scalable, efficient, and compliant manufacturing solutions.

What You Will Do

• Lead process engineering activities for new product introductions and process transfers, ensuring all deliverables are completed in accordance with established development procedures.
• Ensure product and process quality by developing, implementing, and maintaining manufacturing processes that meet operational, material, and regulatory specifications.
• Select manufacturing equipment and components based on technical requirements, reliability analysis, and regulatory standards.
• Develop and execute process validation activities, including PFMEA, Control Plans, SOPs, PPAP documentation, capability studies, and Measurement System Analysis (MSA).
• Analyze process and equipment performance through testing, data collection, and statistical evaluation to support continuous improvement and manufacturing readiness.
• Lead or support capital equipment acquisition activities, including equipment specification, vendor coordination, installation, qualification, and validation.
• Review and approve validation and quality documentation while ensuring compliance with Good Manufacturing Practices (GMP) and safety requirements.
• Train manufacturing personnel and provide technical guidance during product launches, process implementation, and manufacturing scale-up activities.

Required Qualifications

What You Will Need

• Minimum Bachelor's degree in Mechanical Engineering or a related Engineering discipline.
• Minimum 2 years of experience in a manufacturing, process engineering, product development, or research and development environment.
• Experience with manufacturing processes, materials, product design, or process design.
• Ability to read and interpret engineering drawings and technical specifications.

Preferred Qualifications

• Experience in a regulated industry such as medical devices, pharmaceuticals, aerospace, or other highly regulated manufacturing environments.
• Experience supporting process validation, verification, or qualification activities.
• Knowledge of Design for Manufacturing (DFM), statistical analysis tools, and process capability methodologies.
• Experience applying structured problem-solving techniques to manufacturing or product design challenges.

$77,700 - $129,500 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.