Senior Software Engineer
Nitto Denko Asia Technical Centre Pte. Ltd.| Date Posted: 5-Jul-2020
Bachelor's / Honours
- Work closely with electrical, firmware and software engineers to develop software architecture documentation.
- Collaborate with stakeholders to write firmware and software requirements and develop software requirements specifications.
- Lead software risk management, software verification and validation activities.
- Own and write medical device software life cycle development processes and procedures.
- Work closely with firmware QA and testing teams either from Contract manufacturer or Software consultant.
- Work closely with design assurance, quality systems and regulatory teams to achieve company goals.
- 5+ years of experience working on Class II and Class III medical devices (Preferably software classification A and B )
- BS, MS in computer science.
- Demonstrated applied expertise in FDA requirements (21 CFR 820)( Preferably) and medical device regulations including ISO 13485, ISO 14971, IEC 60601, IEC 62366, and IEC 62304.
- Solid understanding of medical device cyber security and privacy guidelines and regulations (e.g, GDPR).
- Experience working on connected medical devices (mobile and cloud supported devices).
- Solid experience in preparing technical files for supporting regulatory submissions (including CE mark, US FDA).
- Strong working knowledge of support tools (e.g., Jira, Github)
- Good written and oral communication skills and experience writing SRS, software architecture documents, test protocols and reports.
Interested candidates, kindly send in your CV with current salary, expected salary & commencement date.
We regret to inform that only shortlisted candidates will be notified.
Nitto Denko Asia Technical Centre Pte. Ltd.