Staff Engineer, Advanced Operations
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.
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.
United States of America Pay Ranges:
USN: $89,300 - $148,800 USD Annual
US20: $107,200 - $178,600 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%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.