Senior Staff Engineer, Advanced Operations

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.

What you will do:

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

What you need:

• 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.

Preferred skills:

• 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

$102,600 - $171,000 USD Annual