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Principal Engineer, Design Assurance Job

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Date: Feb 21, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

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.


Principal Engineer, Design Assurance


About the role:

The Design Assurance Principal Engineer is a quality engineer that directly supports medical device product development from concept through commercialization. This position will work with a high performance cross-functional development team to establish and maintain the design control deliverables, risk management activities, and DHF compliance within Interventional Cardiology to ensure delivery of the highest quality product to the customer.


Your responsibilities include:

  • Actively promote and participate in a cross-functional team to lead timely and effective completion of product development deliverables from concept through commercialization.
  • Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Leads verification, validation, and usability test planning, documentation, and execution for new products and changes to commercial designs to meet or exceed internal and external requirements.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Lead review and monitoring of field performance for recently launched and established medical devices against risk assessments
  • Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables


What we’re looking for:

Minimum qualifications:

  • Bachelor of Science degree in an Engineering discipline or related field of study
  • 8+ years of experience in design assurance, new product development, or related medical device experience
  • Self-motivated with a passion for solving problems and a bias for action
  • Hands-on approach to product development
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies.
  • ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis


Preferred qualifications:

  • Previous development of complex medical device system experience.
  • Previous experience with developing capital equipment as a medical device.
  • Previous experience with leading, influencing, and contributing through others.


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.


Requisition ID: 472982


Nearest Major Market: Minneapolis

Job Segment: Medical, Manufacturing Engineer, Design Engineer, Engineer, Product Development, Healthcare, Engineering, Research