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Quality Assurance Software Engineer I Job

Remote Eligible:  Hybrid
Onsite Locations(s): 

Marlborough, MA, US

Additional Locations:  N/A

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: N/A; US-MN-Arden Hills; US-MN-Maple Grove


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.


Software Quality Systems Engineer I


About the Role 
Cybersecurity is such a prevalent part of the medical device industry with lots of guidance and regulations in the industry. This role will help you learn how to break down these regulations and apply them into actionable steps for employees that are building a medical device. Approximately Fifty percent (50%) of the time will be supporting quality controls for cybersecurity and the other time will be learning and executing software validation.

Software Quality Systems Engineer is an entry level role that supports the development, establishment and maintenance of quality-engineering procedures which meet BSC, customer and regulatory requirements related to securely designing and maintaining medical devices. This role will be in addition to an existing team that acts as the Global Quality representative(s) to improve awareness, visibility, and communication on quality initiatives as they relate to cybersecurity quality goals and priorities. Will also provide quality engineering support for software validation, verification, and documentation. This is a learning role with mentorship, guidance, and direction to reach the criteria above. Join this team, grow your skillset, and become a valued member!


Your responsibilities include: 

  • Work with Quality Systems team and mentors to learn how we embed quality system controls within a medical device.
  • Assists in supporting and enhancing the operational processes for Quality System Post Market and Premarket cybersecurity. 
  • Performs and contributes to quality system impact assessment of cybersecurity regulations, guidance’s or standards related to determine changes needed to quality systems processes.
  • Supports development and maintenance of Quality Systems processes (work instruction, knowledge sharing documents, standard operating procedures) needed for pre and post market product cybersecurity.
  • Collaborated with cross functional team members and R&D product teams to create a consistent product security maturity profile.
  • Provide Quality support for Global Product Cybersecurity engineering including collaboration with BU R&D, IT and other BSC functions.
  • Perform administrative and design tasks in DocuSign.
  • Self-starter working on growing your skills through education, training, conferences, or other means.
  • Collaborate with experienced cybersecurity staff to identify and close knowledge gaps.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.


What we’re looking for:

Required Qualifications

  • A Bachelor’s Degree in Security Engineering, Information Technology, Computer Science, Electrical Engineering, or related field.
  • Excellent written and verbal communication skills is required for effective collaboration with multi-functional and multi-national team members
  • Understanding of the software development lifecycle and methodologies
  • Demonstrated cybersecurity education and/or experience
  • Ability to identify and implement process improvement opportunities
  • Ready to learn new areas (e.g. products, tools, people)


Preferred Qualifications

  • Infrastructure and Cyber / Information Security Strategy experience in healthcare or related industries 
  • Experience performing risk and threat assessments as part of product development
  • Experience learning new software applications
  • Previous experience of a large team with assignments in all phases of the software lifecycle (requirements, design, construct, test, support) and have strong skills in documenting work
  • Experience working in Med Device or other regulated industry
  • Experience working in a broader enterprise/cross-division business unit model
  • Project management experience
  • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization 
  • Understanding of quality system requirements (e.g., FDA, ISO 13485, ISO 9001)
  • Experience working on cross-functional teams such as IT engineering, products teams, legal and compliance


Requisition ID: 515719


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: Boston

Job Segment: Medical, Quality Engineer, Developer, Engineer, Healthcare, Engineering, Quality, Technology

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