At Shire, we are proud and grateful to employ military veterans and thank them for their contributions to our company and our country. See where your military experience can play a role at Shire by using our military skills translator job search tool below:
Purpose:
You are responsible for:
Support the security activities in collaboration with a multidisciplinary team, which includes product/security developers, clinical specialists, product managers, system engineers focus on other aspect (e.g. requirement engineering and risk management) and security professionals. Those activities include:
Conduct security related documentations, including internal design control documents and external customer faced documents in compliance with the related standards (ISO 81001 series) and authorities’ (e.g. NMPA, EUMDR, FDA) requirements.
Analyze post-market data and identify security issues, support the incident response and the implement of post-market security updates or patches.
Support to plan, execute and report security related activities (security scan and test) and ensure critical findings are fixed.
To succeed in this role, you should have the following skills and experience:
Education: Bs degree or above in computer science, biomedical engineering, electrical and electronic engineering or other relevant academic background.
Minimum 3 years’ experience of security developing/security management of complex systems, medical devices experiencer or security certification (e.g. CISSP) obtained preferred.
Good knowledge and understanding of regulation requirements for security of medical devices not limited on: FDA guidance, EU MDR cybersecurity guidance, NMPA software/cybersecurity guidance, ISO 27000 series; familiar with ISO 80001 series, UL2900 series, ISO 62304 and IEC 60601-4-5 will be priority considered.
Good understanding of quality systems (QMS) and risk management principles.
Preferred: experience in the healthcare domain; fluently English that can use English as a working language (above CET-6, or IELTS 6.5, TOEFL iBT 80, or have experiencing on global R&D project will be more appropriate).
Other Competencies and Skills:
Highly independent and pro-active.
Good communication, presentation, and leadership skills.
Ability to “speak up” and reasonable and effectively advocate for cybersecurity needs: by balancing the potential conflict between security design and agile, efficient development and user experience.
Ability to collaborate with multidisciplinary professionals and stakeholders.
Ability to write high quality formal documentation.
Fluency in English and Chinese, written and verbal.