Staff Project Engineer Advanced Operations
Portage, WI - USA
Job Summary
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:
Bachelors 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:
$89300 - $148800 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 contractors legal duty to furnish information.Required Experience:
Staff IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more