Senior Staff Engineer, Advanced Operations

Stryker Group; Portage, Northern (MI, KY); Hybrid; USD 103,000 - 171,000; Full time

Job summary

Stryker Group in Portage, MI is seeking a Senior Staff Process Engineer, Advanced Operations to transfer cutting-edge surgical product designs from R&D into production. You will lead process development for transfer molding and related technologies, ensuring quality and timely launches.

You will collaborate with cross-functional teams, define specifications, conduct capability studies, and generate validation documentation to meet GMP and safety standards while training manufacturing staff on

Qualifications

• Bachelor’s degree in engineering.
• 6+ years of manufacturing or process engineering experience.
• Expertise in plastic injection molding, polymers, and plastic assembly methods.
• Ability to read and interpret complex engineering drawings and GD&T.
• Experience solving manufacturing/design technical issues with validated methods.
• Ability to lift up to 20 pounds and assemble small parts.
• Ability to operate small hand tools and inspection equipment.

Responsibilities

• Design transfer for new product introductions with focus on plastic molding.
• Define specifications and conduct capability studies to ensure quality.
• Evaluate components and equipment for specs and reliability.
• Lead capital acquisition from spec to installation and validation.
• Perform root cause analyses and experimental tests using statistical methods.
• Create and approve GMP-compliant validation documentation.
• Provide training to manufacturing teams on new processes.

Skills

Plastic injection molding

Polymers

GD&T

Root cause analysis

Statistical methods

Process engineering

Quality assurance

Drawing interpretation

Equipment selection

Test planning

Education

Bachelor’s degree in engineering

Tools

CAD

Job description

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 experiencerequired
• 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 andtolerances
• 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/verificationtechniques

$102,600 - $171,000 USD Annual