Project Engineer - Advanced Operations

Position: Staff Project Engineer - Advanced Operations
## Staff Project Engineer - Advanced Operations Apply locations:
Portage, Michigan time type:
Full time posted on:
Posted Yesterday job requisition :
R566885

Work Flexibility:
Hybrid
*
* Position Summary:

** You will play a key role in bringing new products from concept through commercialization by developing and validating manufacturing processes. This role partners cross-functionally to ensure high-quality, efficient, and compliant product launches.
*
* Key Responsibilities:

*** Develop and implement
** manufacturing processes
** to support new product introductions from design transfer through launch
* Design and select
** equipment and process solutions
** based on product, quality, and regulatory requirements
* Execute
** process validations (IQ, OQ, PQ)
** and support development of validation documentation
* Analyze process performance using
** data, experiments, and statistical methods
** to improve capability and resolve issues
* Apply
** structured problem-solving tools
** to establish parameters, improve yield, and drive continuous improvement
* Partner with
** R&D, Quality, Manufacturing, and Project Management
** to ensure successful product commercialization
* Develop manufacturing documentation including
** PFMEA, Control Plans, SOPs, and PPAPs
*** Support
** capital equipment projects**, including specification, installation, and implementation
* Train manufacturing teams and ensure smooth transition to production
* Ensure compliance with
** GMP, safety, and regulatory requirements
*** Communicate project status, risks, and outcomes to stakeholders
*
* Minimum Qualifications:

*** Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related)
* 4+ years of experience in manufacturing, process development, or new product introduction
*
* Preferred Qualifications:

*** Experience in regulated industries (medical device, pharma, automotive, etc.)
* Experience with process validation, statistical analysis, and manufacturing technologies
* Lean/Six Sigma experience
** United States of America Pay Ranges:**$89,300 - $148,800 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.
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