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Quality Engineer II Job

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Date: Apr 4, 2019

Location: Marlborough, MA, US, 01752

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.


Quality Engineer II—Design Assurance


About the role:

A Design Assurance Quality Engineer (Sustaining Engineering) is responsible for assuring all requirements for the Product Development Process (PDP), Risk Management, Design Controls, Usability Testing, and External Manufacturer Production Controls are met. Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.   Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. 


Responsibilities include:

  • Identifies and implements effective risk management, usability, process and design controls to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external quality and regulatory requirements.
  • Provides project direction on departmental or cross-functional engineering initiatives.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Ensures design changes are vetted for potential product performance impact and any risks are mitigated.
  • Owns and effectively leads non-conforming event investigations or CAPAs as required
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support internal and external regulatory audits.
  • Advise management on potential improvements or enhancement to quality systems and processes in the company.


What we’re looking for in you:

  • Education & Experience:
  • Minimum of a BS in Electrical, Mechanical, or Biomedical Engineering
  • Minimum of 2 years of Medical device engineering experience;
  • Travel approximately 10-15% of the time
  • Experience with or knowledge of the following areas:
    • Risk Management
    • Design Changes
    • FMEAs
    • Design Verification & Validation & Usability
    • Test Method validation
    • Packaging Validation
    • Labeling Requirements/Controls
    • Non-Conforming Events / CAPA’s
  • Familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Basic understanding and working knowledge of US and International regulations including 21 CFR,820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, EN 62366, and IEC 62304.
  • Strong communication and presentation skills.
  • Competent with use of Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent).


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: 442528


Nearest Major Market: Boston

Job Segment: Quality Engineer, Medical, Manufacturing Engineer, Engineer, Engineering, Healthcare, Quality