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Design Verification and Valida...
The successful candidate will conduct Design V&V (Verification & Validation) activities as an active member of project teams designing and developing medical devices and software. Devices are mechanical and electro-mechanical systems with embedded software or stand-alone software, intended for use by patients with sleep and respiratory disorders. Software applications are developed for the Web, Client Server, Android and/or iOS platforms.
BS in Engineering, Computer, or other Science discipline required.
At least two (2) years of Quality Assurance experience.
- Disciplined, regulated industries, medical device experience preferred, including FDA’s 21 CFR 820/ISO 13485 experience.
- Software development using ISO 62304 or equivalent.
- Risk Management using IEC 14971 and IEC 60601 or equivalent.
The successful candidate will be responsible for analyzing and verifying product requirements and designs and testing the products at various levels to ensure that the products meet the requirements and intended use. Tasks include:
- Analyzing product and sub-system requirements.
- Analyzing and verifying medical device designs.
- Writing detailed test procedures that evaluate medical devices and systems against documented mechanical, electrical and software requirements.
- Executing test procedures on a Web, Client Server or Mobile phone platform.
- Maintaining and controlling test execution records using good lab and documentation practices.
- Technical writing, including development of test reports.