Senior Staff Engineer, Advanced Operations

StrykerPortage, MI
Onsite

About The Position

As a Senior Staff Process Engineer, Advanced Operations, you will play a pivotal role in transferring cutting-edge surgical product designs from R&D into production. This position requires expertise in process development, specifically with transfer molding and related technologies. Collaborating with cross-functional teams, you will ensure the seamless launch of high-quality products, enhancing both patient outcomes and operational efficiency. This is an onsite position in Portage, MI.

Requirements

  • Bachelor’s degree in engineering
  • 6+ years of manufacturing engineering or process engineering experience required
  • Expertise in plastic injection molding, polymers, and plastic assembly methods (e.g., adhesives, welding)
  • Ability to read and interpret complex engineering drawings and can understand geometrical dimension and tolerances
  • Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
  • Good instincts and sound judgement for mechanical and structural design
  • Ability to lift up to 20 pounds to move equipment.
  • Ability to work with and assemble small objects and component parts.
  • Ability to operate small hand tools, inspection equipment, and other office equipment.

Nice To Haves

  • Tooling design experience
  • Experience in R&D, new product development, or process design
  • Experience in an FDA regulated or regulated industry
  • CAD experience
  • Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques

Responsibilities

  • Support new product and process introductions, ensuring adherence to Stryker’s new product development protocols, with a focus on plastic injection molding.
  • Guarantee process and product quality by defining and adhering to specifications, conducting capability studies, and generating inspection documentation.
  • Evaluate components and equipment based on specifications, reliability, and regulatory requirements, and collaborate with quality engineers to develop testing protocols.
  • Lead activities from equipment specification and negotiation to installation and validation.
  • Conduct root cause analyses, process reviews, and experimental tests, leveraging statistical and validation techniques.
  • Create and approve validation documentation, ensuring compliance with GMP and safety standards.
  • Provide training to manufacturing team members on new processes and technologies.

Benefits

  • 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.
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