Senior Cybersecurity Quality Systems Engineer

Boston Scientific Gruppe; Marlborough (MA); Hybrid; USD 89,000 - 170,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Boston Scientific Corporation in Marlborough, MA is seeking a Senior Cybersecurity Quality Systems Engineer to lead cybersecurity quality activities within Global Software Quality. You will review cybersecurity documentation and ensure alignment with Quality System requirements across the product lifecycle.

You will collaborate with R&D, Product Security, Regulatory Affairs, and Quality teams to drive improvements, monitor evolving cybersecurity regulations, and develop procedures, checklists,

Qualifications

• Bachelor's degree in Computer Science, Cybersecurity, Software Engineering, Computer Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.

Responsibilities

• Serve as the Global Software Quality SME for cybersecurity Quality System processes across medical devices, software, and connected systems.
• Perform independent reviews of cybersecurity documentation and product development deliverables to ensure alignment with Quality System requirements.
• Review cybersecurity objective evidence and SBOMs to verify proper planning, execution, and approval of cybersecurity activities.
• Provide objective feedback and recommendations to improve cybersecurity documentation and process compliance.
• Collaborate with R&D, Product Security, Systems Engineering, Software Engineering, Regulatory Affairs, and Quality teams to resolve gaps.
• Support cybersecurity design reviews and development milestones by evaluating deliverables against procedures and regulatory expectations.
• Develop and improve Global Software Quality procedures, checklists, templates, and guidance related to medical device cybersecurity.

Skills

Cybersecurity

Quality Systems

Regulatory compliance

Documentation review

Cross-functional collaboration

Education

Bachelor's degree in a relevant technical field

Job description

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Senior Cybersecurity Quality Systems Engineer

Onsite Location(s):

Marlborough, MA, US, 01752

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:

Bachelor's degree in Computer Science, Cybersecurity, Software Engineering, Computer Engineering, Biomedical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.

Minimum of5 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 specificprohibited substancetest 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: Boston
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