Sr. Compliance/Standards Engineer

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Sr. Compliance/Standards Engineer Position Description 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. Position 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. *  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 related duties as assigned. *  May attend project meetings to represent Compliance Engineering. Basic Qualifications *  A  Bachelor's degree in electrical engineering or related discipline. *  Minimum 5 years Experience with Safety standards and product compliance and certifications. Desired/Preferred 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. Physical Job Requirements Normal   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an euqal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/employment   Click here to see other Medtronic opportunities  Email this Job to a Friend