Boston Scientific Digital Health Senior Quality Engineer 

United States, Minnesota 

472488800

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
  

Maximum Salary: $ 156900

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.