Senior Process Engineer, Advanced Operations (AO)
Stryker
Summary
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.
Job description
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.
Requirements
- 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
- 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
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.