Senior Compliance Engineer Job

Date: Jan 18, 2018
Location: Valencia, CA, US, 91355
Company: Boston Scientific
Additional Locations: (n/a)
Purpose and Passion ? Comprehensive Benefits ? Life-Work Integration ? Community ? Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose?improving lives through your life's work.
About the role:
Provide expert support for standards compliance for new and existing products. Mitigate technical and budgetary risks.. Conduct and supervise a broad range of testing for standards related verification/validation testing. Utilize expert experimental methods and statistical techniques. Lead standards assessment work including , scheduling reviews, planning, test execution, report generation, and assuring compliance to applicable standards. Work with outside labs for evaluation & testing. Continuously monitor standards revision in process, make organization aware of new work item. Participate in Industry standards bodies.
Your Responsibilities include:
Primary responsibility standards compliance (IEC60601, ISO14708, etc).
Work with outside labs for evaluation & testing.
Continuously monitor standards revision in process, make organization aware of new work items.
Provide guidance of required standards for new product development team.
Participate in at least one standards committee (AAMI, IEC, ISO)
Reach across organization for support (RA, R&D, Labeling, DFU, DQA, Risk Assessment).
Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
Summarizes, analyzes, and draws conclusions from complex test results.
Works cooperatively with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success.
May train and/or provide work direction to technicians and entry-level engineers.
What we're looking for:
Bachelor's Degree
5+ years of experience
High level understanding of entire Implantable Medical System; Labeling; DFU (Marketing); DQA; RA; ME, EE, SW, FW.
High level knowledge of EMC compliance & testing.
High level knowledge of Electrical safety compliance & testing.
High level knowledge of Data Security.
Excellent project management skills.
Excellent verbal and written communication skills (communicate across organization, and outside organization in standards committees).
Detail oriented.
About us
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.
Boston Scientific is an Equal Opportunity Employer ? Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran
Requisition ID: 406853
Nearest Major Market: Los Angeles
Job Segment: R&D Engineer, Medical, Compliance, Manufacturing Engineer, Electrical, Engineering, Healthcare, Legal

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