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Quality Engineer II - Design Assurance Job

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Date: Jul 18, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


Design Assurance Engineer II -Peripheral Interventions 


About the role:
The Design Assurance Engineer provides support with high visibility which will provide the right candidate with excellent growth potential.  Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to SE include internally developed products, Sourced Finished Medical Devices and acquired products. SE Design Assurance engineer works in close partnership with Research and Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.


Your responsibilities include:

  • Actively promote and participate in a cross-functional teamwork environment.
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
  • Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
  • Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports
  • Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
  • Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
  • 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 to comply with associated regulatory requirements and internal standards.
  • Perform regulatory standard assessments and support regulatory submissions to notified bodies.
  • Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).

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’s degree in an Engineering discipline or related field of study
  • 2+ years of experience in design assurance, new product development or related medical device / regulated industry 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
  • Travel as required (10%)


Preferred qualifications:

  • Previous development of complex medical device system experience
  • Experience interfacing with physicians to gather insight into new product concepts and associated risk
  • Previous experience with developing capital equipment as a medical device
  • Audit experience



Requisition ID: 479612


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


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.

Nearest Major Market: Minneapolis

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