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Principal Quality Systems Engineer, Design Controls/Risk Management Workstream Lead (Remote) Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Arden Hills, MN, US, 55112


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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.


About the role:
This is an exciting opportunity to join the EP/Baylis Quality Integration team as a Principal Quality Systems Engineer, specifically as the Design Controls and Risk Management workstream lead. This position is looking for an experienced Design Assurance professional, ideally with integration expertise in Quality Engineering for medical devices including design controls, risk management, usability, test method development, post-market surveillance, continuous improvement, and problem-solving. In this position as the Design Control/Risk Management integration workstream lead, you’ll collaborate with members of the Quality Integration Team, functional SMEs as well as peers and leadership from the Baylis Quality Management System to ensure efficient and compliant integration of design deliverables into the BSC quality system.   The individual in this role may also provide coaching to cross-functional teams and implement guidance for best practices for design quality as it relates to integration practices. Seeking an individual with a strong desire to analyze and drive Design Control integration solutions within the EP division. 

Your responsibilities will include:

  • Provide guidance regarding quality integration strategies and approaches to assessing Design Control related documents and records for potential compliance gaps; provide in-depth and complex data/problem evaluation and analysis
  • Applying advanced analytical skills by evaluating both qualitative and quantitative data including synthesizing large data sets by identifying key themes/information 
  • Demonstrated competency in implementing effective BSC design controls/risk management procedures to support the development of products to meet or exceed internal and external requirements.
  • Assist in determining remediation strategies of acquired entity’s records, as necessary, for Design Control processes
  • Collaborate with the integration team to identify and implement compliant and efficient integration plans related to Design Control processes
  • Assess, update and recommend integration activities for Design History File, Design Input / Output, and Risk documentation (i.e. Hazard Analysis, Fault Tree, FMEAs)
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Partner with team to drive implementation of post-market surveillance plans and reports
  • Acts as an effective leader in supporting quality disciplines, decisions, and practices

What we’re looking for in you:
Minimum requirements:

  • Bachelor's degree in Science, Health, Engineering, or related discipline
  • Minimum of 7 years of medical device design control and risk management experience
  • In-depth familiarity with the FDA, ISO, MDD, EU MDR, and the medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Strong communication (oral and written) and presentation skills.
  • Strong project management skills 
  • Self-motivated with a passion for solving problems and a bias for action
  • Ability to manage multiple priorities and work with ambiguity 
  • Proven use of Quality tools and methodologies
  • Ability to effectively work and collaborate in a remote environment 

Preferred experience:

  • Acquisition/integration experience



Requisition ID: 528984


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.


Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Nearest Major Market: Minneapolis

Job Segment: Controls Engineer, Risk Management, Medical, Quality Engineer, Manager, Engineering, Finance, Healthcare, Management

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