Job description

Work Flexibility: Onsite 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 Travel Percentage: 20% Stryker Corporation is an equal opportunity employer. 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. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Requirements

Must-haves

Work Flexibility: Onsite
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.
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
$102,600 - $171,000 USD Annual
Travel Percentage: 20%

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: workday
Effort: long