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Boston Scientific Corporation

Senior Compliance Engineer Job

Boston Scientific Corporation - Valencia, CA

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:

*Selects techniques to solve complex problems and make sound design recommendations. *Summarizes, analyzes, and draws conclusions from complex test results. *Designs and prepares complex reports to communicate results to technical community. *Designs and coordinates complex engineering tests and experiments. *Coordinates, manages, and documents project goals and progress and recommends appropriate revisions. *Responsible for engineering documentation. *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. *Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables. *Primary responsibility sustaining standards assessments  (IEC60601, ISO14708, etc). *Reach across organization for support (RA, R&D, Labeling, DFU, DQA, Risk Assessment). *Work with outside labs for evaluation & testing. *Continuously monitor standards revision in process, make organization aware of new work items. *Become a member of AAMI, IEC, ISO standards bodies. *Participate in at least one standards committee. *Provide guidance of required standards for new product development team.

What we're looking for:

Qualifications

*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

 

Requisition ID: 380153

 

12 days 11 hours ago

Boston Scientific Corporation

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Senior Compliance Engineer Job Boston Scientific Corporation - Valencia, CA, United States

   

Location: Valencia, CA

Company Profile:
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.