Staff Engineer, Advanced Operations

Work Flexibility: Hybrid or Onsite

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:

• Bachelors degree in Mechanical Engineering or a related engineering discipline.
• Minimum 4 years of engineering experience in manufacturing process development product development or a related field.
• Minimum 4 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:

• 7 years of experience supporting regulated manufacturing environments
• 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: $89300 - $148800 USD Annual

• US20: $107200 - $178600 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 contractors legal duty to furnish information.