Staff Process Engineer, Advanced Operations

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Stryker offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.

As a 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 plastic injection 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.

WHO WE WANT:

• Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

• Self-directed innovators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

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

• 4+ 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.

Preferred skills:

• Specialization or work experience in plastics or polymers

• Experience in R&D, new product development, or process design

• Experience in an FDA regulated or regulated industry

• Good understanding of Design for Manufacturing related statistical tools and validation/verification techniques