Digital Health Senior Quality Engineer

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 no