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Design Assurance Engineer II - Healthcare Solutions and Digital Health (Remote)

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): 

Maple Grove, MN, US, 55311

Location options: This position can be remote or located on any US-based major Boston Scientific campus.

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: 
The Design Quality Assurance Engineer II will support design assurance for healthcare and digital health solutions that improve the delivery of care for customers and patients around the world.  This role will work with colleagues in Marketing, IT, R&D, device Design Assurance, Legal, Supplier Management, and Regulatory Affairs to provide quality support to new solution development and to commercial solutions and applications.  This role will provide quality engineering support to design requirements, verification and validation outputs, risk management, design change control, and privacy and cybersecurity assessments for medical and health software applications within the Peripheral Interventions business. 
Key responsibilities include: 

  • As a member of a collaborative team, ensure quality system requirements are met during the development of health software and software as a medical device (SaMD). 
  • Applies BSC QS requirements to projects and provides input to divisional and global teams to improve and evolve the quality system.
  • Manage or advise on Design Requirements from inception through the product lifecycle, inclusive of change management and EOL activities
  • Help interpret and facilitate the application of global regulations and quality system requirements for internal BSC customers and external partners. 
  • Author software validation plans as part of a cross-functional product development team.
  • Assess changes to software and determine the impact to safety, security, and privacy.
  • Collaborate with physical product and software teams to determine change impact across systems.
  • Review and provide input to vendor contracts, with follow-up as needed to understand the solution, delineate pre-and post-market responsibilities, and to ensure the vendor is capable of meeting internal and external quality requirements. 
  • Audit existing healthcare solutions and digital health projects against internal and external requirements. 
  • Communicate within quality group about new or evolving regulations for software, privacy, and cybersecurity.
  • Collaborates remotely and in-person using technical tools to accomplish project tasks, ie TEAMS, Microsoft Office suite

What we're looking for in you

Minimal qualifications: 

  • Bachelor’s level degree in Science/Engineering/Software discipline 
  • 2+ years of related work experience in a regulated industry (e.g., medical device, automotive, or aerospace) 
  • Comfortable working with ambiguity as digital solutions and regulations evolve 
  • Experience working with a diverse population of internal and external customers 
  • Comfortable speaking and presenting to colleagues and business partners 
  • Strong written and verbal communication skills, including technical tools supporting communication
  • Creative and innovative thinking skills 
  • Experience managing project deliverables to completion 
  • Comfortable working as part of a cross-functional team 

Preferred Qualifications: 

  • Knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485
  • Experience with software development standards including IEC 62304 and IEC 82304
  • Experience working with Agile software development teams
  • Experience with risk management  per ISO 14971
  • Experience with cloud platforms (e.g. Amazon Web Services, Salesforce) and IoT 
  • Experience with a variety of development tools (GitLab, Bitbucket, JIRA, Pivotal Tracker, InDesign, etc.) 


Requisition ID: 538449


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: Cloud, Medical Device Engineer, Regulatory Affairs, Compliance, PLM, Technology, Engineering, Legal, Management

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