Senior Embedded Software Engineer
Date Submitted: 08-03-2021 | End date: 08-04-2021
| Industry Specialization | : | |
| Type of Employment | : | Permanent |
| Minimum Experience | : | 5 years or more |
| Work Location | : | West Singapore |
Job Description:
- Design and develop embedded software/firmware using C programming languages for new products or design changes of existing products.
- Lead/participate in software design & development, implementation and testing, troubleshooting and documentations for the pilot/engineering/V&V/production stages of medical devices
- Collaborate with stakeholders to develop software requirements specifications. Responsible for software implementation and integration, ensuring products are according to design requirements.
- Work closely with hardware and mechanical engineers to develop product software architecture and corresponding documentation, e.g.: technical specifications, UML diagrams, and code description.
- Lead/participate in software risk management, impact analysis, regression analysis, software verification and validation activities.
- Work closely with cross functional teams or external suppliers e.g. Contract manufacturer or consultants.
- Work closely with design assurance, quality and regulatory teams to achieve company goals.
Requirements:
- 5+ years of embedded firmware development experience (preferably medical device software class B and C as per IEC62304 standard)
- Bachelor’s, master’s or PhD in electrical/electronic or computer science
- Demonstrated applied expertise in FDA requirements and medical device regulations including IEC 62304, ISO 13485, and ISO 14971.
- 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 software development and configuration management tools (e.g., Jira, Git)
- Excellent written, oral communication and documentation skills