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Sr. Software Quality Engineer - Global Digital Health 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:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s): US-MN-Arden Hills

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.

 

 

 

 

 

The Sr. Software Quality Engineer - Global Digital Health will champion the application of the Boston Scientific Quality System to the development and commercialization of Digital Health Products and Services at BSC.

 

This Global role will work with colleagues in IT Digital Health, Quality Systems, Marketing, Legal, Supplier Management, and Regulatory Affairs to provide quality support to the development and maintenance of Digital Health services and applications. This role will provide software quality engineering leadership to the IT Digital Health Teams in areas such as design requirements, verification and validation, risk management, usability, Vendor Onboarding, change control, problem resolution, CAPA, real world performance, & post market surveillance, privacy and cybersecurity assessments for medical and health software applications.

 

Your responsibilities will include:

  • Leads, guides and monitors the project team on the application of global and functional Digital Health processes to ensure compliance.
  • Serves as Independent Reviewer and approves project documentation, artefacts and deliverables created for Digital Health initiatives.
  • Applies 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. 
  • Lead all aspects of software quality in a globally regulated environment, to ensure development and sustaining activities are carried out in compliance with global policies and departmental procedures.
  • Plays a key role in driving change that is influenced through BSC’s Partnership with the FDA and as guided by the FDA’s ‘Software Precertification Program’
  • Evaluate and manage safety, security, and privacy risks for medical and health software applications according to the associated regulations and internal requirements. 
  • Facilitate Digital Health meetings with partners in marketing, regulatory, legal, supplier management and Digital Health product development to drive actions to completion. 
  • Acts as an effective Project Manager in supporting and delivering IT Digital Health Initiatives.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues.
  • Plays a key role in vendor management by identifying the quality system needs from a vendor and ensures that vendors are qualified in a manner that enables smooth integration with the BSC quality system.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 

What we are looking for in you:

 

Minimum Qualifications: 

  • Minimum of a bachelor’s degree in a science, engineering, or a software/programming related discipline 
  • Minimum of 4 years of related experience, including supporting Quality Assurance for Digital Health or related discipline
  • 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 presenting internal and external customers, including executive leadership teams
     

Preferred Qualifications

  • Clinical background or knowledge of clinical evaluations and User Centered Design beneficial
  • Experience/Understanding of risk management as per ISO 14971 
  • Experience with CAPA, Vendor Onboarding, Complaint Handling and External Audits 
  • Basic Understanding of HIPAA/GDPR and data security regulations
  • Some experience/knowledge of AI/ML and Data Analytics beneficial
  • Some experience/knowledge of Cybersecurity and related Security Risk Analysis
  • Some experience/knowledge of digital platforms and development tools (Salesforce, GitLab, Bitbucket, JIRA, Pivotal Tracker, InDesign, etc.)
  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 and cGxP for Medical Devices
     

 

Requisition ID: 534654

 

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.

 

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Nearest Major Market: Minneapolis

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