Overview
On Site
Full Time
Skills
Recruiting
Sustainability
SAFE
Research and Development
Regulatory Affairs
Innovation
Quality Assurance
Design Controls
Inspection
Testing
Design Review
Risk Analysis
Test Methods
Process Improvement
Product Development
Mentorship
Regulatory Compliance
Collaboration
Continuous Improvement
Mechanical Engineering
Electrical Engineering
Materials Science
Biomedical Engineering
Data Collection
Data Analysis
Risk Management
Corrective And Preventive Action
Auditing
Statistics
Medical Devices
ISO 13485
GDP
GMP
Six Sigma
Legal
Job Details
Work Flexibility: Hybrid or Onsite
Senior Engineer, Advanced Quality Engineering
Stryker is hiring a Senior Engineer, Advanced Quality, for our Sustainability Solutions team supporting our reprocessing product line. In this role, you'll be part of a team that ensures innovative medical devices are safe, effective, and compliant. You'll collaborate across R&D, Regulatory Affairs, and Operations to deliver products that improve patient outcomes worldwide. If you're passionate about quality and innovation, this is your chance to make a real impact.
Work Flexibility:
What You Will Do
What You Will Need
Required Qualifications
Preferred Qualifications
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.
Senior Engineer, Advanced Quality Engineering
Stryker is hiring a Senior Engineer, Advanced Quality, for our Sustainability Solutions team supporting our reprocessing product line. In this role, you'll be part of a team that ensures innovative medical devices are safe, effective, and compliant. You'll collaborate across R&D, Regulatory Affairs, and Operations to deliver products that improve patient outcomes worldwide. If you're passionate about quality and innovation, this is your chance to make a real impact.
Work Flexibility:
- Hybrid; must reside within a commutable distance to Tempe, AZ and be onsite at least 3 days per week.
What You Will Do
- Represent Quality Assurance on cross-functional New Product Development teams to meet project milestones.
- Lead Risk Management activities, including creating and maintaining Risk Management Files and ensuring compliance with design control procedures.
- Plan, design, and implement inspection and testing methods using advanced statistical techniques to ensure product reliability.
- Conduct and lead Design Reviews to confirm design robustness and regulatory compliance (QSR, ISO 13485).
- Perform and review engineering risk analyses, test methods, and process improvements to enhance quality and efficiency.
- Guide product development by interpreting test data and developing protocols for processes and products.
- Mentor junior team members and lead departmental initiatives to drive quality and compliance.
- Collaborate with internal teams and customers to address product quality concerns and support continuous improvement.
What You Will Need
Required Qualifications
- Bachelor's degree in Mechanical, Electrical, Chemical, Material Science, Biomedical Engineering or related field
- 2+ years of experience in an engineering role.
- Experience in data collection, data analysis, and applying scientific methods.
Preferred Qualifications
- Experience with Quality concepts such as Risk Management, CAPA, Audits, and Statistics.
- Previous experience in the medical device industry.
- Knowledge of U.S. and international medical device regulations, including ISO 13485, GDP, and GMP.
- Six Sigma Green Belt or ASQ Certified Quality Engineer (CQE).
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.