Senior Engineer, Design Quality

Work Flexibility: Hybrid or Onsite

Senior Engineer, Design Quality  

Stryker is hiring a Senior Engineer, Design Quality in Fremont, CA to support our Neurovascular business! In this role, you will be responsible for developing qualification plans and protocols, performing product testing and failure analysis, and writing technical reports.

Work Flexibility: Hybrid. 

The candidate must reside within a commutable distance to Fremont, CA and is expected to be onsite at the facility multiple times/week.

 What you will do:

• Support fast-paced product design change efforts.
• Utilize problem-solving tools and statistical analysis for test method development, validation, design verification, risk assessment, and design reviews.
• Oversee product risk management and ensure adherence to design control requirements throughout the product lifecycle.
• Create and maintain risk files while assessing the impact of necessary product changes.
• Collaborate with Medical Safety, R&D, Marketing, and Regulatory Affairs to remediate existing risk files and align with current best practices.
• Work on innovative Neurovascular products that push technological boundaries, ensuring safety, performance, and compliance.

What you will need: 

Required

• Bachelor’s degree in Engineering, Science or similar field  
• 2+ years of experience in a technical role as an Engineer
• Experience in Design Control, Risk Management, and Statistical Analysis  

Preferred

• 2+ years of experience in a Medical Device or Pharmaceutical industries  
• Experience in Human Factors/Usability Engineering

$100,400.00 - $160,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

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.