Job Description
Boston Scientific
Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.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.
About the role
The Senior R&D Cybersecurity Engineer will work alongside the R&D team to iterate on existing commercial products and perform new product development activities. The Senior R&D Cybersecurity Engineer will develop system architectures and cybersecurity requirements. Provide input into detailed sub-system requirements throughout the product development lifecycle from a medical device cybersecurity compliance perspective. You will contribute to process improvements (customer experience, manufacturing and servicing), conduct risk assessments, and support regulatory submissions, ensuring compliance with industry standards. This role involves close collaboration with cross-functional teams to evaluate and validate systems.
Your responsibilities will include:
- Own the product’s cybersecurity file as per external standards and internal processes.
- Participate in developing system architectures for existing and new product developments in terms of Cybersecurity for medical devices.
- Own security risk assessments for medical devices products in development and commercialized.
- Perform threat modeling activities for products in development.
- Participate in conducting secure code reviews.
- Document cybersecurity plans and reports.
- Perform cybersecurity vulnerability scans on medical device software.
- Own post-market cybersecurity deliverables for products commercialized (i.e., Vulnerability disclosures and monitoring).
- Perform penetration testing on products in development and coordinate with Global Product Security for any formal tests.
- Share lessons learnt from penetration tests carried out on products to the design team.
- Assess feasibility of new technologies prior to a new product development project through research, bench studies, and pre-clinical evaluation.
- Participate on project teams to translate cybersecurity requirements into design requirements (e.g., system, hardware, software, firmware, mechanical, electrical, interface, etc.) consisting of system/sub-system specifications.
- Evaluate Medical Device cyber security standards like ISO 27000, AAMI-TIR57 and FDA Guidance to update and its applicability to the medical device product.
- Contribute to product risk assessment activities and perform Design FMEA’s activities.
- Assist Regulatory with product submissions.
- Work with a cross-functional team and serve as an R&D representative on cross-functional deliverables.
- Continuously improve processes and work methodologies (using agile/lean principles to eliminate waste) to help solve complex, interdisciplinary problems by interfacing with peers/cross-functional groups.
Required qualifications:
- Bachelor or Masters of Electrical, Biomedical, Computer Science, or equivalent.
- 5+ years of experience with product development activities in a regulated industry.
- Experience in Cybersecurity Engineering.
- Experience in troubleshooting test failures.
- Strong problem-solving skills in a team environment.
- Excellent organizational, communication and collaboration skills.
Preferred qualifications:
- At least 4 years of experience leading product development teams in a Medical Regulated Environment.
- Experience in performing FDA Medical Device Submissions.
- Experience in performing EU MDR Medical Device Submissions.
- Experience in performing Japan Medical Device Submissions.
- Experience in working on medical devices used in electrophysiology such as therapy or diagnostic devices (ablation and mapping systems).
- Strong knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Knowledge of ISO 14971.
- Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization.
Requisition ID: 594153
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!
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