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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.

Quality Engineer II

About the role:

This position is an opportunity to work for a world wide and diverse company who puts patients first. Through this position, the ideal condidate would develop, establish and maintains quality engineering methodologies, systems, and practices which support customer and regulatory requirements for new product development (NPD) within the Urology Division of Boston Scientific (BSC).  Serves as a Design Assurance (DQA) representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.  Provides focused quality engineering support within new product development, operational, or system/services support

Your responsibilities include:

• Support the DQA project team through the development effort of a single use design (SUD) balloon product for support of Percutaneous Nephrolithonomy (PCNL) procedures in compliance with Quality System and external requirements (eg. EN 13485 / CFR820).
• Support/create Risk Management Planning, Reporting and the development of critical risk documentation in compliance with BSC procedures and external standards (eg. EN 14971).     
• Support Usability Engineering and planning documentation  in compliance with BSC procedures and external standards (eg. EN 62366)
• Interface with the core team and support the development effort for both product and packaging designs.
• Complete/support design change documentation as necessary
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• May perform other duties as directed

What we’re looking for in you:

Basic Qualifications:

• Bachelor’s degree in related field with 2-5 years of experience
• Experience with Design Control Systems
  • Risk Management
  • Design Changes
  • FMEAs
  • Design Verification & Validation
  • Test method validation
  • Packaging validation
  • Labeling requirements/controls
  • Non-Conforming Events / CAPA’s
• Experience within following systems preferred:
  • PLM/Windchill
  • GCS2
  • MiniTab
• Medical Device Experience Preferred
• Strong organization, execution and communication skills required

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

Boston Scientific maintains a drug-free workplace.  Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Requisition ID: 471976