Principal Engineer- Advanced Operations

Stryker Corporation; Irvine (CA); On-site; Confidential; Full time

Job summary

Stryker Corporation in Irvine, CA is seeking a Principal Advanced Operations Engineer - Technical Lead to drive manufacturing excellence across development stages. Lead cross-functional teams to optimize processes, validate equipment, and transfer technology from R&D to production, ensuring readiness for new product launches.

The role requires deep expertise in lean manufacturing, quality systems, automation, and project leadership, with a track record of delivering scalable, compliant

Qualifications

• Bachelor's degree in Engineering or related field.
• 8+ years of progressive experience in manufacturing engineering, operations, or new product implementation.
• 5+ years leading complex technical projects and cross-functional teams.
• Master's degree preferred.
• Experience in regulated industries.
• Experience with process validation, equipment qualification, lean manufacturing, and continuous improvement methodologies.
• Experience influencing both leaders and individual contributors cross functionally.

Responsibilities

• Serve as the technical lead for advanced manufacturing and operations engineering initiatives supporting new product development, implementation, and commercialization.
• Provide strategic direction for manufacturing process development, optimization, scale-up, operational readiness, and technology transfer to production.
• Partner with R&D throughout the product development lifecycle to ensure manufacturability and scalability and drive engineering best practices through Design for Manufacturing (DFM) and Design for Assembly (DFA).
• Lead continuous improvement initiatives focused on safety, quality, delivery, and cost performance.
• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution.
• Collaborate with Quality, Supply Chain, Manufacturing, Regulatory Affairs, and R&D to deliver successful product launches and process implementations.
• Lead multidisciplinary project teams, influence organizational stakeholders, and drive alignment on technical and operational decisions.
• Provide technical expertise in lean manufacturing, Six Sigma, advanced manufacturing processes, automation, and process validation methodologies.

Skills

Lean manufacturing

Six Sigma

Project leadership

Cross-functional collaboration

Process validation

Automation

Quality systems

Education

Bachelor's degree in Engineering

Master's degree (preferred)

Tools

IQ/OQ/PQ protocols

Lean tools (5S, Kaizen)

Regulatory compliance knowledge

Job description

Work Flexibility: Onsite The Principal Advanced Operations Engineer - Technical Lead is a senior technical leader responsible for driving manufacturing excellence, process development, technology transfer, and operational readiness for new product launches. As the primary manufacturing and operations engineering authority within R&D, this role leads cross-functional initiatives to enhance manufacturability, improve operational performance, and accelerate commercialization. The position requires expertise in manufacturing engineering, process validation, lean manufacturing, automation, quality systems, and project leadership.

Key Responsibilities:

• Serve as the technical lead for advanced manufacturing and operations engineering initiatives supporting new product development, implementation, and commercialization.
• Provide strategic direction for manufacturing process development, optimization, scale-up, operational readiness, and technology transfer to production.
• Partner with R&D throughout the product development lifecycle to ensure manufacturability and scalability and drive engineering best practices through Design for Manufacturing (DFM) and Design for Assembly (DFA).
• Lead continuous improvement initiatives focused on safety, quality, delivery, and cost performance.
• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution.
• Collaborate with Quality, Supply Chain, Manufacturing, Regulatory Affairs, and R&D to deliver successful product launches and process implementations.
• Lead multidisciplinary project teams, influence organizational stakeholders, and drive alignment on technical and operational decisions.
• Provide technical expertise in lean manufacturing, Six Sigma, advanced manufacturing processes, automation, and process validation methodologies.

Qualifications:

• Required: Bachelor's degree in Engineering or related field.
• 8+ years of progressive experience in manufacturing engineering, operations, or new product implementation.
• 5+ years leading complex technical projects and cross-functional teams.
• Preferred: Master's degree.
• Experience in regulated industries.
• Experience with process validation, equipment qualification, lean manufacturing, and continuous improvement methodologies.
• Experience influencing both leaders and individual contributors cross functionally.

United States of America Pay Ranges: US15: $135,700 - $226,200 USD Annual 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.

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.