Senior Process Engineer, Advanced Operations (AO)

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

Job summary

Stryker Corporation in Portage, MI, onsite role within the Advanced Operations team, delivering process engineering expertise across product launches, transfers, equipment validation, and manufacturing readiness.

You will collaborate with cross-functional teams to develop scalable, efficient, and compliant manufacturing solutions while ensuring GMP compliance and quality requirements are met throughout scale‑up and transfer activities.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field is required.
• Minimum 2 years in manufacturing/process engineering or R&D.
• Ability to read and interpret engineering drawings and technical specifications.

Responsibilities

• Lead process engineering activities for new product introductions and transfers.
• Develop manufacturing processes meeting quality/regulatory specifications.
• Select manufacturing equipment based on technical requirements and regulatory standards.
• Develop and execute process validation activities including PFMEA, Control Plans, SOPs, PPAP, MSA.
• Analyze process and equipment performance to support continuous improvement and readiness.
• Lead or support capital equipment acquisition activities (specification, vendor coordination, installation, validation).
• Review and approve validation/quality documentation ensuring GMP compliance.
• Train manufacturing personnel during launches, implementations, and scale-up.

Skills

Process engineering

Manufacturing knowledge

Reading drawings

Statistical tools

Education

Bachelor's degree in Mechanical Engineering

Job description

Work Flexibility: Onsite 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.

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.

Salary & Travel

• $77,700 - $129,500 USD Annual Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.