Senior Staff Engineer, Advanced Operations

Stryker Corporation; Portage, Northern (MI, KY); Hybrid; Confidential; Full time

Job summary

Stryker Corporation in Portage, MI is seeking a Senior Staff Process Engineer in Advanced Operations to transfer cutting-edge surgical product designs from R&D into production, focusing on injection molding and related technologies. You will design transfer, define specifications, perform capability studies, validate processes, and lead capital acquisitions, with rigorous documentation and GMP compliance.

This onsite, full-time position requires a 6+ year manufacturing/process engineering

Qualifications

• Bachelor’s degree in engineering and 6+ years of manufacturing/process engineering experience.
• Expertise in plastic injection molding, polymers, and plastic assembly methods.
• Ability to read and interpret complex engineering drawings and tolerances.
• Experience in executing complex problem-solving techniques related to manufacturing/design issues.
• Familiarity with GMP and safety standards.

Responsibilities

• Design transfer of new products focusing on plastic injection molding.
• Define specifications, conduct capability studies, and document inspections.
• Evaluate components, equipment, and test protocols with quality engineers.
• Lead capital acquisition from specification to installation and validation.
• Perform root cause analyses and validation testing.
• Create validation docs and ensure GMP compliance.
• Train manufacturing teams on new processes.

Skills

Plastic injection molding

Polymers

Reading engineering drawings

Problem solving

Education

Bachelor’s degree in engineering

Tools

CAD experience

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.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces!

For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.