Senior Manufacturing Engineer

Stryker; Cary (AR); On-site; USD 86,000 - 143,000; Full time

Job summary

Stryker is seeking a Manufacturing Engineer to join an onsite, highly automated production facility in the United States. You will lead equipment validation, FAT activities, and process improvements in a regulated environment.

The role emphasizes developing FMEAs, control plans, IQ/OQ/PQ validations, and writing SOPs while ensuring GMP compliance and reliable production performance.

Qualifications

• Bachelor’s degree in Engineering or a related technical field is required.
• At least 2 years of full-time experience in manufacturing engineering or related discipline.
• Experience supporting manufacturing operations and production equipment.
• Experience troubleshooting automated manufacturing equipment.
• Experience implementing process improvements in a manufacturing environment.

Responsibilities

• Support FAT, equipment installation, commissioning, and startup activities for new manufacturing equipment and automation systems.
• Develop and maintain process FMEAs, control plans, and other process documentation for new and existing production lines.
• Execute and document process validation activities, including VP, URS, IQ, OQ, and PQ.
• Create and maintain SOPs, work instructions, and GMP-compliant documentation.
• Monitor production line performance, investigate issues, and lead structured problem-solving initiatives to improve reliability, efficiency, and quality.

Skills

Manufacturing operations experience

Troubleshooting automated equipment

Process improvements

Education

Bachelor’s degree in Engineering or related field

Job description

Work Flexibility: Onsite

Join a manufacturing engineering team that supports the production of medical device, drug, and cosmetic products in a highly automated, regulated manufacturing environment. This role provides technical leadership for manufacturing processes and equipment, with a focus on supporting automation systems, validating new equipment, and driving operational performance in a world-class production facility.

What You Will Do

• Support factory acceptance testing (FAT), equipment installation, commissioning, and startup activities for new manufacturing equipment and automation systems.
• Develop and maintain process Failure Mode and Effects Analyses (FMEAs), control plans, and other process documentation for new and existing production lines.
• Execute and document process validation activities, including Validation Plans (VP), User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Create and maintain standard operating procedures (SOPs), work instructions, and technical documentation in compliance with Good Manufacturing Practices (GMP).
• Monitor production line performance, investigate equipment and process issues, and lead structured problem-solving initiatives to improve reliability, efficiency, and quality.

What You Will Need

Required

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 2 years of full-time experience in manufacturing engineering, mechanical engineering, or a related engineering discipline.
• Minimum 2 years of experience supporting manufacturing operations and production equipment.
• Experience troubleshooting automated manufacturing equipment.
• Experience implementing process improvements in a manufacturing environment.

Preferred

• Bachelor’s degree in Mechanical, Electrical, Controls, Industrial, Biomedical, or Manufacturing Engineering.
• Minimum 2 years of experience in the medical device industry.
• Experience writing, executing, and documenting process or equipment validations, including IQ, OQ, PQ, or related protocols.

United States of America Pay Ranges:

$85,500 - $142,500 USD Annual

Travel Percentage: 10%

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.