Physio-Control - Sr. Compliance/ Standards Engineer - Redmond WA in Redmond, WA at Stryker Corporation

Date Posted: 7/26/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Redmond, WA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/26/2018
  • Job ID:
    31534BR

Job Description

Who we want
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. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices. 
Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision. 


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 the creation and revision of Technical Documentation files. 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. MAJOR


• 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.

• Leads the preparation and revision of Technical Document Files and other certification reports from engineering documentation.

• Helps create and maintain overall isolation diagrams.

• Guides engineering project teams in designing new or revised products that will be compliant.

• Ability to manage several projects and work on internal and external department teams.

• Provide a weekly status report.

• Implements engineering documentation of high complexity.

• Develops design and process changes under the direction of more senior engineers.

• Perform other duties as assigned.

• May attend project meetings to represent Compliance Engineering.


What you have

• A  Bachelor's degree in electrical engineering or equivalent combination of education and experience.

• Minimum 5 years’ experience with safety standards, product compliance and certifications.


Preferred experience

• Familiarity with IEC standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, ISO 17025, ISO 14971, CE-Mark, Technical Documentation Files and safety agencies like UL, CSA, TUV and BSI

• 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 computer skills with mid-range knowledge of Word, Excel and PowerPoint

• Good written and verbal communication skills.

• Understand basic analog circuits and components.

• Familiarity with safety standards evaluation, test and certification processes.


Where you'll work

• Office environment

• Heavy use of computer

• Sitting and standing

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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