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Quality Engineer - Design Assurance in Fremont, CA at Stryker Corporation

Date Posted: 3/8/2019

Job Snapshot

Job Description

Who we are

At Stryker Neurovascular, we design, develop and manufacture state-of-the art devices that treat stroke patients, improve outcomes and save lives! Our approach to Complete Stroke Care centers around a culture of innovation and partnerships - from introducing breakthrough technologies and investigating leading-edge therapies, to providing ongoing training and improving reimbursement.

It's time to join Stryker!

Stryker Neurovascular in Fremont is experiencing phenomenal growth. This is a great time to join us. We are dynamic, passionate, and accomplished individuals who thrive on tackling challenging assignments with just one mission- provide, ‘Complete Stroke Care’ solutions to our patients.

Our Quality team collaborates with our cross functional partners to develop innovative devices such as stent retrievers, coils, stents for adjunctive use with coiling, and intracranial atherosclerotic stents.  We value the strengths of each team member and are focused on individualized development opportunities that align with career aspirations.

Together we can advance our capabilities and continue to improve healthcare and the lives of patients. Stryker is well positioned to continue serving the worldwide medical community for generations to come. Do you have what it takes to change the world with us?

Who we want

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Quality Engineer - Design Assurance you will support a fast-paced mix of short design change efforts and longer term NPI (New Product Introduction) projects. You will be responsible for developing qualification plans, protocols, performing product testing, failure analysis and report writing. You will also be creating and maintaining risk files and assessing the impact of necessary changes to our products. You will be responsible for product risk management and adherence to design control requirements throughout the product life-cycle.

  • Develops qualification plans, protocols, and reports, for existing products, new products, sub-assemblies, and parts.
  • Implements testing and inspection methodology.
  • In accordance with risk management, design control, and quality procedures, the engineer plans, writes protocols and provides reports.
  • Perform failure analyses and defect investigations.
  • Analyzes and recommends revisions of specifications and processes.
  • Participates on team projects and completes assignments.
  • Other duties as assigned

What you need

  • Bachelor’s degree in Engineering, Biomedical or Mechanical preferred
  • 0-3 years’ experience
  • ISO 14971 – risk management in support of NPD

Work From Home: No

Travel Percentage: Up to 25%

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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