Senior Process Engineer, Advanced Operations (AO)

Stryker Group; Portage, Northern (MI, KY); Hybrid; USD 78,000 - 130,000; Full time

Job summary

Stryker's Advanced Operations (AO) team in Portage, MI is seeking a process engineer to support successful introduction of new products and manufacturing processes.

You will lead process engineering activities for launches and transfers, develop scalable manufacturing processes, validate, and ensure GMP and safety compliance while collaborating across functions.

The role emphasizes device manufacturing readiness, equipment qualification, and training of personnel during scale-up.

Qualifications

• Requires a Bachelor's degree in Mechanical Engineering or related field.
• 2+ years in manufacturing, process engineering, product development, or R&D.
• Experience with manufacturing processes, materials, product design, or process design.
• Ability to read and interpret engineering drawings and technical specifications.

Responsibilities

• Lead process engineering activities for new product introductions and transfers.
• Develop manufacturing processes that meet operational, material, and regulatory specs.
• Select manufacturing equipment and components based on requirements and standards.
• Develop and execute process validation activities (PFMEA, Control Plans, SOPs, PPAP, MSA).
• Analyze process and equipment performance using testing and statistics for continuous improvement.
• Lead or support capital equipment acquisition including installation and qualification.
• Review validation and quality documentation to ensure GMP compliance and safety.
• Train manufacturing personnel and provide technical guidance during launches and scale-up.

Skills

Process engineering

Engineering drawings reading

Data analysis

Education

Bachelor's degree in Mechanical Engineering or related 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.

What You Will Need

Required Qualifications

• 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