Process Engineer, Advanced Operations - Michigan, Portage 1941 Stryker Way

Work Flexibility: Hybrid

Stryker’s Instruments division is looking to hire a Process Engineer, Advanced Operations in Kalamazoo, Michigan to support the new product/process introduction team. As a Process Engineer, Advanced Operations you will have the opportunity to work on new product process development focusing on interventional spine products.

WHO WE WANT:

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

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• 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:

As a Process Engineer you will use the latest engineering techniques to reduce product time to market whilst adhering to regulatory requirements, project deadlines and product costs. 

ADDITIONAL RESPONSIBILITIES INCLUDE:

• Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.

• Ensure quality of process and product as defined in the appropriate operation and material specifications.

• Will select components and equipment based on analysis of specifications, reliability and regulatory requirements. Work with quality engineers to develop component specific testing and inspection protocols.

• May support capital acquisition activity from specifying equipment, contract negotiation, installation and validation.

• Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches.

• Complete capability studies for in process inspection and generate subsequent Inspection documentation.   

• Conduct MSA studies and provide training for new products and new processes.

• Review and approval of validation documentation.

WHAT YOU NEED:

• ​​Bachelor’s degree in engineering - required, mechanical or electrical engineering highly preferred

• 0+ years of related engineering experience - preferred

• Design for Manufacturing including statistical tools and validation/verification techniques - required

• Experience in an FDA regulated or regulated industry - preferred

Travel Percentage: 10%

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.