Nitto Denko Asia Technical Centre Pte. Ltd.

Senior Software Engineer

Nitto Denko Asia Technical Centre Pte. Ltd.| Date Posted: 29-Jul-2020
Save Job
Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

Key Responsibilities

  • 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.

 Qualifications

  • 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.

Company Overview
Nitto Denko Asia Technical Centre Pte. Ltd.