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Digital Health Senior Quality Engineer

Work mode:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s):  N/A

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 Senior Quality Engineer - Healthcare Solutions and Digital Health will be responsible for leading quality system deliverables and reviews within cross-functional teams for the innovative Peripheral Interventions Digital Health (DH) and Software as a Medical Device (SaMD) products. These products are developed internally or in partnership with external software vendors. This role supports a major product category with high visibility, which will provide growth potential to the right candidate with excellent technical and Quality system leadership skills. In addition to supporting product teams in the areas of software design, development, verification, validation, and maintenance throughout the full Software Development Lifecycle, this candidate can serve as a Quality representative to support departmental, divisional and corporate quality goals and priorities.

Your Responsibilities Will Include:

  • As a leading member of a cross-functional team, ensure quality system requirements are met during the internal and external development of health software and software as a medical device (SaMD) for Design Activities, Risk Management Activities, and Post-Market Surveillance, including
  • Manage or advise on Design Requirements from inception through product lifecycle, inclusive of change management and end of life (EOL) activities.    
  • May author software validation plans as part of a cross-functional product development team. 
  • Partner with cross-functional and Security team to perform the privacy and security risk analysis process, including understanding of threat modeling and penetration testing. 
  • Demonstrates sound problem-solving skills in support of the issues tracking process, e.g. Jira, associated with the software products during the design life cycle. 
  • Develop and maintain understanding of the product and therapy space, including clinical use applications, to effectively integrate this knowledge with functional quality management system requirements.
  • Leads the cross functional team in creating and reviewing non-conformances and CAPAs, including the use of problem-solving tools, as needed to drive compliance of these programs.   
  • Mentors cross-functional team members through Quality System processes.

What We're Looking For In You
Required Qualifications:

  • Bachelor’s level degree in Science/Engineering/Software discipline 
  • 4 or more years of related work experience in a regulated industry 
  • Comfortable navigating ambiguity as digital solutions and regulations evolve
  • Understanding and demonstrated use of IEC 62304
  • Strong communication skills (verbal & written) as well as presentation skills 
  • Creative and innovative thinking skills to solve problems and bring solutions to implementation 
  • Experience managing projects and project deliverables to completion 
  • Capable of working effectively in a hybrid environment as well as with a highly matrixed and global team
  • Travel approximately <10%

Preferred Qualifications:

  • Use and understanding of regional and international quality system requirements including ISO 13485, ISO 14971, 21 CFR 820
  • Experience with a variety of digital platforms and development tools (Salesforce, GitLab, Bitbucket, JIRA, InDesign, etc.
  • Experience with Class III Medical Devices
     

 

 

 

Requisition ID: 603324 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

 

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.  


Nearest Major Market: Minneapolis

Job Segment: Testing, Medical Device, Senior Quality Engineer, Medical Device Engineer, PLM, Technology, Healthcare, Engineering, Management

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