Senior Quality Engineer, Advanced in San Jose, CA at Stryker Corporation

Date Posted: 11/10/2019

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.

What you will do

Stryker’s Sports Medicine business delivers a wide range of innovative sports medicine solutions – from implants and biologic products for soft tissue repair and healing, to pre-operative surgical planning software and surgical tools for accurate soft tissue and boney resection - our focus is on minimally invasive and open approaches to the shoulder, knee, hip, and small joints. Our goal is to enable our customers to restore a patient’s normal lifestyle after an injury, explained in our motto of “motion regained, life renewed”. We are excited to continue expanding our diverse team, where we strive to create an inclusive culture, grounded in Stryker’s mission and values.

As a Senior Quality Engineer, you will be a core member of our Sports Medicine new product development team.  Their primary focus is to bring innovative products to market that meet the high-quality standards of our customers.    Stryker Sports Medicine is the fastest growing segment within the Endoscopy business, helping our customers to advance the treatment of sports medicine procedures through advanced technological solutions.  

  • Identify Critical Quality Attributes and identifies the most effective steps to ensure these attributes are controlled (though inspection, process selection, etc). 
  • Manage risk management activities throughout the design and development process
  • Leads Design Validation activities to ensure Defined User Needs have been met
  • Perform DFMEA analysis early in the project to identify weaknesses in components.
  • Familiar with competitor's products design, user interface, and potential failure modes.
  • Ensure that Defined User Needs & Design Inputs are complete and accurate
  • Involvement across project team on testing and execution strategy.  Participates in Design Verification and Design Experimentation.  Help define Verification & Validation protocols.
  • Understand clinical uses and applications of product.  Perform human factors evaluation of product and take steps to address usability concerns
  • Visit clinical facilities and health care providers (HCP) to gather use data to further develop and improve clinical knowledge, use cases, and potential applications for medical devices
  • Spends time in lab with Design team experimenting with prototypes to proactively identify potential issues, and works with the cross-functional team to determine root causes and implement solutions
  • Utilize a variety of statistical methods throughout the design control process to inform product design decisions and to support verification and validation activities
  • Help define Customer Preference Testing  and Limited Launch parameters
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
  • Networks with internal and external personnel to gather feedback from subject matter experts.
  • Post launch monitoring of newly launched product and incorporate lessons learned in future products
  • Timely review of documents as agreed upon by the project team

What you need

Basic Qualifications:

  • Bachelor's degree in Engineering  
  • Minimum 3 years’ experience in engineering, quality, manufacturing, r&d, or related.

Preferred Qualifications:

  • Some understanding of US and International medical device regulations desired, as well as experience interacting with regulatory agencies (FDA, notified bodies, etc.).
  • Blueprint/engineering schematic reading and interpretation.
  • Excellent written and oral communication skills.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Proficient on basic computer programs Excel, Word, PowerPoint.
  • Ability to deal effectively with a diversity of individuals at all organizational levels.
  • Working knowledge of data collection, data analysis, evaluation, and scientific method.
  • Must be able to speak, read, write, and understand the primary language(s) used in the workplace.
  • Must be comfortable in a surgical/cadaveric setting.

Work From Home: Not available

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.

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