Compliance Engineer

Company: Stryker
Location: Redmond
Posted on: May 10, 2022

Job Description:

Why engineering at Stryker?At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-teamWe are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.comOur benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.
WHO WE WANT:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• 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:The primary function is the evaluation of new and revised electro-medical devices and accessories to international safety standards. Responsible for the creation and maintenance of evaluation and certification reports. Responsible for input into the creation and revision of Technical Documentation Files as well as TDF approvals. This includes review of IEC test procedures and reports, compliance to safety standards and requirements, in-house as well as external testing, certifications and requirement checklists. Will need to interface with project teams and other departments.
  • Review and evaluate test data, specifications, engineering and user documentation, physical construction, marking and labeling, hazard analysis, clinical reports, Declaration of Conformity, EMC protocol and test reports and, the technical description of essential components and materials
  • Creation and/or review of Standards Test Report Forms
  • Provides content for the preparation and revision of Technical Document Files and other certification reports
  • Collaborates with engineering project teams in designing new or revised products that will be compliant
  • Ability to work on several projects and partner with internal and external department teams
  • Assist Senior Compliance Engineers with engineering documentation of high complexityWHAT YOU WILL NEED:Must Haves:
    • A Bachelor's degree in electrical engineering or related disciplineNice to Haves:
      • Understanding of IEC standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, as well as particular standards
      • 3 years of related experience in a professional work environment
      • Familiarity with high-voltage circuits and isolation
      • Familiarity with test and measurement equipment operation such as dielectric, leakage and ground impedance testers and DVMs
      • Good written and verbal communication skills
      • Understand basic analog circuits and components
      • Familiarity with safety standards evaluation, test and certification processes
        Know someone at Stryker?Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/About StrykerStryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Keywords: Stryker, Redmond , Compliance Engineer, Engineering , Redmond, Washington