SENIOR COMPLIANCE REGULATORY/STANDARDS ENGINEER

Location: REDMOND, WA
Job Type: Direct Hire
Salary: $95,000.00 - $110,000.00
Degree: Bachelor;
Date: 6/30/2017
Job ID: 02498069
Job Description

SENIOR COMPLIANCE REGULATORY/STANDARDS ENGINEER?

GENERAL SUMMARY

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. This includes review and guidance of IEC test procedures and reports, compliance to safety standards and requirements, in-house as well as external testing, certifications and requirement checklists. Collaboration with project teams and other departments.

MAJOR DUTIES/RESPONSIBILITIES
  • 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.
  • Manage compliance engineering input on projects and work with internal and external teams.
  • Provide a weekly status report.
  • Develop project plans for compliance certification strategy.
  • Implements engineering documentation of high complexity.
  • Develops design and process changes under the direction of more senior engineers.
  • Attend project meetings to represent Compliance Engineering as necessary.
  • Perform other duties as assigned.

 

Requirements

BASIC QUALIFICATIONS:
  • A Bachelor's degree in electrical engineering or related discipline.
  • Minimum 5 years’ experience with safety standards, product compliance and certifications.
PREFERRED / DESIRED QUALIFICATIONS:
  • 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.
WORKING CONDITIONS: 
  • Office environment
  • Heavy use of computer
  • Sitting and standing
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