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Packaging Test Engineer - San Jose, CA - Stryker Corporation

Date de publication : 5/29/2019

Résumé de l'offre

Description de l'offre

Who we want:

Test Engineers work closely with R&D to experiment with early prototypes and vet out product designs throughout the design process.  What this really means is that we get to be the Mythbusters of our division.  You think your design can last the entire expected service life?  We put it to the test.  Just like the show, we quickly design and build fixtures to simulate real life situations.  In addition to these experiments, we are ultimately responsible for design verification – the quantitative testing of the technical specifications of the product.  We are a close-knit team of more than twenty engineers, technicians, and managers.  Our experience ranges from 1 to over 15 years with technical specialties ranging from sterilization, mechanical, electrical, software, optics, packaging, and reprocessing.  If you’re the type of person that has the magic ability to break things – we want you!

What you'll do:

  • Manages, improves, and maintains sterile and non-sterile packaging validations and associated procedures within Total Endoscopy.
  • Maintains internal packaging validation work instructions are compliant and comprehensive per industry accepted procedures.
  • Manages sterile and non-sterile packaging validation from protocol writing and method determination through execution and test report authoring. Works with technicians, engineers, scientists, and outside test houses to ensure timely and high quality test execution.
  • Provides guidance to other departments on packaging testing and adoption criteria as needed.

  • Drives packaging design changes for improved product quality, reduced environmental impact, and cost improvement.

  • Participates in and/or conducts various departmental and interdepartmental meetings or trainings. A team player that can prioritize between multiple projects.

  • Understands the intended use and functional specifications of a device.
  • Performs experimentation on early prototypes and supports testing of new products and designs.
  • Develops test methods that are accurate, time-efficient, and cost-effective.
  • Designs tests to fully measure requirements listed in the functional specifications, including automated test fixtures to execute tests.
  • Verifies fixtures and qualifies test methods used for verification and validation.
  • Maintains a strong relationship with cross-functional team throughout the design and development process.
  • Performs other duties as assigned by manager and mentor.
  • Abides to guidelines set forth by the Quality System Regulation (QSR).
  • Complies with internal and external regulations and quality policies at all times; ensuring a safe, positive work environment.

What you have:

  • 1-3 years of packaging engineering/test engineering experience
  • Bachelor’s degree (B.S.) in Packaging Engineering/Packaging Science (preferred), Mechanical Engineering, Material Science, or Biomedical Engineering
  • Medical device experience preferred
  • Understands ASTM packaging standards and test methods, ISO 11607 packaging standards for sterile medical devices, and ISO 2233 packaging conditions standard
  • Ability to build collaborative relationships quickly and have excellent interpersonal skills
  • Able to analyze complex prints, standards, statistical calculations, and test documentation for compliance and effectiveness
  • Observe and correct minute inconsistencies (e.g. in the printed word, product appearance, etc.)
  • Generate, follow, and explain detailed instructions and design parameters
  • Able to complete detailed documentation accurately
  • Strong technical writing skills for reports, work instructions, protocols, procedures, and correspondence

Work From Home: No

Travel Percentage: None

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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