Staff Engineer, Advanced Operations
Stryker
Summary
Join Stryker as a Staff Engineer supporting New Product Introduction (NPI) and biologics process development. This role provides technical leadership across process design, validation, manufacturing readiness, and supplier collaboration to ensure biologics processes are developed, controlled, and documented in compliance with applicable quality and regulatory requirements. You will work across cross-functional teams to advance new product launches while maintaining a strong focus on process robustness, product quality, and operational excellence.
Job description
What You Will Do
- Lead the development, optimization, and control of upstream and downstream biologics manufacturing processes across internal and supplier operations.
- Conduct process characterization, variability, hold-time, and worst-case condition studies to establish process robustness and define in-process control strategies.
- Evaluate, select, and qualify manufacturing equipment and components based on technical specifications, reliability requirements, and applicable regulations; support equipment installation and validation activities.
- Generate and review technical documentation including PFMEAs, Control Plans, SOPs, PPAPs, validation protocols, capability studies, MSA studies, and inspection documentation to support product launches.
- Mentor engineers, provide technical guidance across multiple product portfolios, and deliver technical updates and recommendations to stakeholders and leadership.
What You Will Need
Required:
- Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
- Minimum 7 years of engineering experience in manufacturing, process development, product development, or a related field.
- Minimum 7 years of experience supporting regulated manufacturing environments.
- Experience developing and validating manufacturing processes, including statistical analysis and verification/validation methodologies.
- Experience interpreting engineering drawings, specifications, and geometric dimensioning and tolerancing (GD&T).
- Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA).
Preferred:
- Experience supporting biologics manufacturing or biologics process development.
- Experience in FDA-regulated or ISO 13485-regulated industries and supporting complex global supply chains.
Requirements
- Bachelor’s degree in Mechanical Engineering or a related engineering discipline.
- Minimum 7 years of engineering experience in manufacturing, process development, product development, or a related field.
- Minimum 7 years of experience supporting regulated manufacturing environments.
- Experience developing and validating manufacturing processes, including statistical analysis and verification/validation methodologies.
- Experience interpreting engineering drawings, specifications, and geometric dimensioning and tolerancing (GD&T).
- Experience with Design for Manufacturing (DFM), process capability studies, and measurement system analysis (MSA).
- Experience supporting biologics manufacturing or biologics process development.
- Experience in FDA-regulated or ISO 13485-regulated industries and supporting complex global supply chains.
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.