Product Quality Engineer - Medical Devices in San Jose, CA at Stryker Corporation

Date Posted: 10/4/2020

Job Snapshot

Job Description

Who we want:

  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Challengers & Influencers.  People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates.  Partners who listen to ideas, share thoughts and work together to move the business forward.


Stryker is hiring a Product Quality Engineer – Medical Devices in San Jose, CA.

What you will do

As part of the Endoscopy Quality team, customers and patients are at the heart of everything we do. Our Product Quality Engineers maintain our brand of high-quality products. In this role, you will:

  • Manage several products and be accountable for ensuring high quality and urgent customer support.   
  • Troubleshoot and root cause customer complaints and develop design recommendations to improve product safety, reliability, or performance.  Develop, test, and implement design changes as well as coordinate with suppliers and manufacturing to ensure smooth implementation. 
  • Scope and lead regular software releases to regularly tackle field defects and top customer pain-points.
  • Debug software code and/or hardware defects when related to product performance
  • Statistically trend post market data to help solve any technical issues that arise from the field.
  • Conduct Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products and assess clinical risk to customer and patients.
  • Visits customer sites to observe OR workflow, surgical procedures, and products in use to support timely quality investigation support
  • Be an ambassador for the customer by providing Input to new product development from post-market experience
  • Support Quality Systems initiatives and non-conformances as it relates to quality product issues. 

What you need

Basic Qualifications

  • Bachelor's degree in Engineering
  • 2+ years of experience in engineering, design, quality, usability/human factors, or related

Preferred Qualifications

  • Engineering degree in Electrical, Computer Science, Software, or Biomedical Engineering with a heavy focus in Electrical or Software
  • 3+ years of related experience in R&D/design, design assurance, usability/human factors, quality, systems engineering
  • Hands-on design experience with software or hardware
  • Root cause analysis and troubleshooting experience
  • Familiarity with ISO 14971, ISO 13485, ISO 60601, ISO 62366, and/or ISO 62304
  • Commitment to excellence and high standards.
  • Excellent written and oral communication skills.
  • Strong organizational, problem-solving, root cause and analytical skills.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Proven ability to handle multiple projects and meet deadlines.
  • Good judgment with the ability to make timely and sound decisions.
  • Acute attention to detail.

Who we are

At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system. We are passionately driven to produce remarkable results and seek team members who exhibit accountability, integrity, and credibility to join us in a highly-engaging, fast-paced environment. We are tight-knit group who frequently enjoy team building activities in and out of office – some of latest activities include pasta-making, cycling trip across the Golden Gate bridge, and a brewery tour! Come join a group comprised of talented individuals who move faster, act quicker, and are empowered to do more as a team!

Work From Home: Occasional

Travel Percentage: 30%

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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