Principal Cybersecurity Design Quality Engineer

Boston Scientific

  • Maple Grove, MN
  • $99,100 per year
  • Permanent
  • Full-time
  • 19 days ago
Additional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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:Boston Scientific is seeking an experienced Principal Design Quality Cybersecurity Engineer with a strong background in the design, development, and testing of cybersecurity features and controls within the Interventional Cardiology division. This individual will be responsible for overseeing and guiding the cybersecurity strategy throughout the product lifecycle, ensuring compliance with relevant standards and regulations.The Interventional Cardiology team is one of Boston Scientific's most product-diverse divisions, supporting in the design of exciting new products and business development activities. These products adhere to industry standards and include computing devices, single-use devices, and support devices. Seeking an individual with a strong desire to analyze and drive solutions that are adaptable in communication to all levels within the organization.At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office three days per week.Relocation assistance is available for this position at this time.Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.Your responsibilities will include:
  • Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
  • Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
  • Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.
  • Self-motivated with a passion for solving problems and a bias for action.
  • Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
  • Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
  • Collaborate in planning of software verification and validation strategies.
  • Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
  • Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
  • Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
  • Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
  • Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
  • Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
  • Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.
What we're looking for in you:Required qualifications
  • Bachelor's degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 9+ years of experience in cybersecurity engineering, with a focus on product development and risk management or Master's degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 7+ years of experience in cybersecurity engineering, with a focus on product development and risk management
  • Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
  • Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
  • In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
  • Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
  • Strong leadership, decision-making, and team-building capabilities.
  • Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
  • Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.
Preferred qualifications
  • 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
  • Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
  • Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
  • Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
  • Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
  • Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
  • Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.
Requisition ID: 611994Minimum Salary: $ 99100Maximum Salary: $ 188300The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see --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.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 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 identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.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.

Boston Scientific