Recruiter: Spencer Gregory Hale
Senior Cybersecurity Quality Systems Engineer
About the role
The Senior Cybersecurity Quality Systems Engineer is a member of the Global Software Quality organization and serves as the Quality Systems subject matter expert for medical device cybersecurity. This role provides operational support to product development teams by independently reviewing cybersecurity documentation and objective evidence to ensure alignment with the Boston Scientific Quality System, Global Software Quality procedures, and applicable regulatory requirements.
The Senior Cybersecurity Quality Systems Engineer evaluates the completeness, consistency, and technical sufficiency of cybersecurity design outputs and supporting documentation to verify that cybersecurity activities have been performed in accordance with established Quality System processes and industry expectations. The role provides objective feedback, identifies opportunities for improvement, and partners with cross-functional teams to strengthen cybersecurity quality, compliance, and continuous improvement throughout the product lifecycle.
In addition, this role serves as a key resource within Global Software Quality by monitoring evolving cybersecurity regulations, standards, and guidance and translating those expectations into Quality System procedures, review methodologies, and organizational best practices.
Your responsibilities will include
Serve as the Global Software Quality subject matter expert for cybersecurity Quality System processes supporting medical devices, software, and connected systems.
Perform independent reviews of cybersecurity documentation and product development deliverables to ensure alignment with the Boston Scientific Quality System, Global Software Quality procedures, and applicable regulatory requirements.
Review cybersecurity objective evidence, including threat models, cybersecurity risk assessments, security requirements, software architecture documentation, verification and validation evidence, vulnerability assessments, Software Bill of Materials (SBOM), and residual cybersecurity risk documentation.
Assess the completeness, traceability, consistency, and technical sufficiency of cybersecurity documentation to determine whether cybersecurity activities have been appropriately planned, executed, documented, reviewed, and approved.
Provide objective feedback and practical recommendations to product teams regarding cybersecurity documentation, Quality System compliance, and process improvements.
Partner with Research & Development, Product Security, Systems Engineering, Software Engineering, Regulatory Affairs, and Quality organizations to resolve documentation and process gaps while maintaining an independent Quality Systems perspective.
Support cybersecurity design reviews and development milestone reviews by evaluating cybersecurity deliverables against internal procedures and external regulatory expectations.
Develop, maintain, and continuously improve Global Software Quality procedures, work instructions, review checklists, templates, and guidance related to medical device cybersecurity.
Monitor changes to global cybersecurity regulations, standards, and industry guidance and assess their impact on the Boston Scientific Quality System.
Lead implementation of Quality System updates resulting from new cybersecurity regulations, standards, and guidance.
Identify systemic trends and recommend continuous improvements to cybersecurity Quality System processes across the organization.
Support internal quality activities, regulatory inspections, CAPA investigations, and quality improvement initiatives involving cybersecurity processes and documentation.
Mentor and educate cross-functional teams on cybersecurity Quality System expectations and documentation best practices.
What we’re looking for in you:
Minimal qualifications:
Bachelor's degree in Computer Science, Cybersecurity, Software Engineering, Computer Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
Minimum of 5 years of experience in medical device software or cybersecurity and/or software quality within med device.
Experience working within a regulated medical device Quality Management System.
Demonstrated knowledge of secure software development lifecycle principles and cybersecurity risk management.
Working knowledge of FDA medical device cybersecurity guidance, IEC 62304, ISO 14971, medical device design controls, and software development processes.
Experience reviewing technical documentation and providing objective assessments of engineering deliverables.
Strong analytical, organizational, written, and verbal communication skills with the ability to collaborate across global, cross-functional teams.
Preferred Qualifications
Demonstrated knowledge of:
FDA Quality Management System Regulation (QMSR)
FDA Premarket and Postmarket Cybersecurity Guidance
IEC 81001-5-1
ISO 13485
AAMI TIR57
AAMI TIR97
NIST Cybersecurity Framework (CSF)
NIST Secure Software Development Framework (SSDF)
Secure software supply chain and Software Bill of Materials (SBOM) concepts
Experience supporting connected medical devices, Software as a Medical Device (SaMD), cloud-connected healthcare solutions, or digital health technologies.
Knowledge of cybersecurity considerations for Artificial Intelligence (AI) and Machine Learning (ML) enabled medical devices and healthcare software.
Experience supporting regulatory inspections, internal quality reviews, CAPAs, and continuous improvement initiatives.
Professional certification such as CISSP, CSSLP, CQE, CQA, CISA, or equivalent.
Requisition ID: 635126
Minimum Salary: $ 89200
Maximum Salary: $ 169500
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.
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 identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
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.
Skills Required
- Bachelor's degree in Computer Science, Cybersecurity, Software Engineering, Computer Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline
- Minimum 5 years of experience in medical device software or cybersecurity and/or software quality within medical devices
- Experience working within a regulated medical device Quality Management System
- Knowledge of secure software development lifecycle principles and cybersecurity risk management
- Working knowledge of FDA medical device cybersecurity guidance, IEC 62304, ISO 14971, medical device design controls, and software development processes
- Experience reviewing technical documentation and providing objective assessments of engineering deliverables
- Strong analytical, organizational, written, and verbal communication skills, with ability to collaborate across global cross-functional teams
- Knowledge of FDA Quality System Regulation, FDA premarket and postmarket cybersecurity guidance, IEC 81001-5-1, ISO 13485, AAMI TIR57, AAMI TIR97, NIST CSF, and NIST SSDF
- Experience with secure software supply chains and Software Bill of Materials concepts
- Experience supporting connected medical devices, Software as a Medical Device, cloud-connected healthcare solutions, or digital health technologies
- Knowledge of cybersecurity considerations for AI and ML-enabled medical devices and healthcare software
- Experience supporting regulatory inspections, internal quality reviews, CAPAs, and continuous improvement initiatives
- Professional certification such as CISSP, CSSLP, CQE, CQA, CISA, or equivalent
Boston Scientific Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.
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Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
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Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
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Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.
Boston Scientific Insights
What We Do
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.
