Product Development Engineering Technician
4 weeks ago
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. p>
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. h3>
- 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.
- 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.) li>
- 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.
- 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.
- 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.
- 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).
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