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Sr. Quality Engineer - Healthcare Solutions and Digital Health (Remote optional) Job

Remote Eligible: 
Onsite Locations(s): 

Maple Grove, US

Additional Locations:  US-AL-Montgomery

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.

Additional Locations: Position can be located in any major US campus location or be 100% remote


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.


Sr. Quality Engineer - Healthcare Solutions and Digital Health 
Apply your skills and experience to transform the global healthcare industry as we know it when you join our Digital Health and Healthcare Solutions quality team at Boston Scientific. Thrive in a culture that prioritizes learning and development, build lasting relationships with colleagues, and truly make a difference to people around the world, and around the corner.  A career with Boston Scientific is more than just a job. As a leader in medical science we are committed to solving the challenges that matter most. If you’re a natural problem-solver with the imagination, courage and spirit to make a meaningful difference, there’s no better place to build your career. With more than three decades of global leadership in the medical device industry, our mission is to transform the lives of patients worldwide by advancing science. With determination, imagination and a deep passion for human life, we are exceeding the boundaries of what was previously thought possible.  
About the role: 
The Sr. Quality Engineer - Healthcare Solutions and Digital Health will champion 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, 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 leadership to design requirements,  verification and validation outputs, risk management, design change control, and  privacy and cybersecurity assessments for medical and health software applications. 
Key responsibilities include:

  • Apply in depth knowledge of the quality system and familiarity with various software development methodologies to influence process development and improvement strategies that balance quality requirements with agile development methodology. 
  • Develops, establishes, and maintains Digital Health quality methodologies, systems, and practices which meet BSC, customer, and regulatory requirements including safety, security, privacy risks for medical device stand alone software (SaMD) as well as Health Software. 
  • Lead all aspects of design assurance and software quality in a globally regulated environment to ensure development and sustaining activities are carried out in compliance with global policies and procedures. 
  • Interpret and facilitate the application of global regulations and quality system requirements for internal BSC customers and external partners. 
  • Assess existing healthcare solutions and digital health projects against internal and external requirements. 
  • 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. 
  • Facilitate Digital Health & Healthcare Solutions meetings with partners in marketing, regulatory, legal, supplier management and product development to drive actions to completion. 
  • Communicate similarities and differences in the product development process between software and physical products to colleagues in partner functions. 
  • Communicate broadly within the organization regarding new or evolving regulations for software, privacy, and cybersecurity. 

Minimal qualifications: 

  • Bachelor’s level degree in Science/Engineering/Software discipline 
  • 4-6 years of related work experience in a regulated industry 
  • In depth knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485 
  • Experience in working with ‘Agile’ software development methodologies
  • Experience supporting projects that have followed the requirements as laid out in IEC 62304 for Device Software and/or as laid out in IEC 82304 for Health Software 
  • Experience with risk management (ISO 14971) 
  • Experience with CAPA, Vendor Controls, and External Audits 
  • Experience working with a diverse population of internal and external customers 
  • Flexible, positive attitude 
  • Comfortable speaking and presenting to leadership 
  • Strong written and verbal communication skills 
  • Creative and innovative thinking skills 
  • Experience managing projects and project deliverables to completion 
  • Comfortable working independently and as part of a cross-functional team 
  • Ability to manage multiple priorities and work with ambiguity 

Preferred qualifications: 

  • Knowledge of regional and international requirements for medical device software, health software, privacy, security, and electronic signatures, HIPAA/GDPR
  • Clinical background or knowledge of clinical/clinic support workflows 
  • Experience with digital analytics software 
  • Experience with a variety of digital platforms and development tools (Salesforce, GitLab, Bitbucket, JIRA, Pivotal Tracker, InDesign, etc.) 



Requisition ID: 511409


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

Job Segment: Medical, Quality Engineer, Engineer, Product Development, Healthcare, Engineering, Quality, Research

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