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Senior Engineer, Design Quality

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Fremont, CA, 94536, US
Job details
Work flexibility: Hybrid or Onsite Req ID: R538740 Employee type: Full Time Job category: Engineering Travel: 10% Relocation: No

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Job description

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

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