This is a defined term assignment with an anticipated  start date of March 2026 and end date of December 2027.

The Senior Manufacturing Engineer role will support engineering/manufacturing projects, balancing high-level project management with hands-on technical execution. This individual will be responsible for ensuring Quality Management System (QMS) compliance including NC’s and CAPA’s, equipment validation and documentation, and the seamless physical relocation of manufacturing assets; ultimately supporting a successful site closure and product transfer.

What You Will Do:

• Manufacture knit materials per supply plan.
• Conduct comprehensive QMS gap assessments and execute remediation plans to transition legacy processes into Stryker procedures.
• Author and maintain critical documentation, including NC’s and CAPA’s, and lead the development and execution of equipment and process validation protocols.
• Ensure all manufacturing processes meet or exceed industry standards and regulatory requirements for medical device production.
• Update technical documentation to ensure accuracy and compliance. 
• Coordinate the installation, validation, and repair of mechanical/electromechanical systems.
• Support the physical relocation of machinery between sites, managing everything from logistics to re-validation at the receiving facility.
• Assess single points of failure, establish backup part inventories, and deploy preventative maintenance cadences to ensure long-term operational stability.
• Provide support for knitting and finishing operations.
• Resolve production issues and prevent/repair down lines in manufacturing due to equipment, documentation, etc.

What You Need:

• Minimum of 2+ years of professional engineering experience, preferably within the medical device or a similarly regulated industry.
• Bachelor’s degree in Engineering (Mechanical, Biomedical, or Manufacturing).

Physical Requirements

• Light work: Exerting up to 20 pounds of force occasionally and/or up to 10 pounds of force frequently and/or a negligible amount of force constantly to move objects.
• Must have the ability to work with and assemble small objects and component parts.
• Ability to operate common office equipment (e.g. calculator, PC, telephone, etc.).
• Must have very good visual acuity and demonstrate fine motor skills.