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Senior Quality Systems Engineer Job

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Date: Feb 23, 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.


Senior Engineer Design Assurance - for CCI team


About the role:

The Design Assurance Senior Engineer is a quality engineer who supports medical device product development from concept through commercialization.  Design Assurance engineers work with high-performance cross-functional team members 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.  Specifically, this engineer will support our Compliance and Continuous Improvement (CCI) team and will support and improve the quality systems and practices used by our teams rather than execute design control activities for a product. This engineer facilitates, implements, and drives continuous improvement initiatives in the areas of Design Controls, Risk Management, and Post Market Surveillance.


Your responsibilities include:

  • Actively promotes and participates in a cross-functional and cross-divisional environment.
  • Demonstrates expert knowledge and application of Design Control, Risk Management, and Post-Market Surveillance.
  • Coaches and mentors cross-functional team members in the application of the Design Control, Risk Management, and Post-Market Surveillance requirements to their products through formal classroom training, wiki content, functional meetings, and team and individual consulting.
  • Develops divisional implementation strategy for changes within the quality system, including developing training, communication, change management strategy, & self-serve guidance for teams to execute the strategy; documenting plans, ensuring plan completion, & securing support of key stakeholders for the change.
  • Engages to represent the division on various global and multi-divisional quality system improvement projects by proactively soliciting input from IC teams, reviewing proposals to assess impact on IC, and advocating for IC needs amongst global counterparts. Champions change, and as applicable, owns quality system NCEPs, CAPAs, and project plans relating to Design Control and Risk Management.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Successfully navigates in grey spaces and provides logical and creative guidance to teams.
  • Demonstrates good working knowledge and application of regulatory requirements and internal expectations.
  • Monitors regulatory submission & audit questions and responses, proactively communicates lessons learned to internal customers, and assists teams with response writing for quality system-related questions.
  • Works with internal customers who represent related and interconnected processes such as Management Review, Design Controls, Risk Management, Cybersecurity, Production and Process Control, Clinical, Medical Safety, Regulatory, and Complaint handling.  


What we’re looking for in you:

Minimum qualifications:

  • Bachelor’s degree in an Engineering discipline or related STEM field of study
  • 3-5 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:

  • 5+ years of experience in design assurance, new product development, risk management, or product lifecycle management
  • Previous development of complex medical device system experience
  • Previous experience with developing capital equipment as a medical device
  • Experience working with cross-functional groups such as Regulatory, Research & Development, Clinical, Quality, Operations, and Complaints Handling



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: 473221


Nearest Major Market: Minneapolis

Job Segment: Quality Engineer, Medical, Senior Quality Engineer, Systems Engineer, Engineering, Quality, Healthcare