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Medical Device Software Assurance Specialist
3 weeks ago
We are seeking a highly skilled Software Design Assurance Engineer to join our team. The successful candidate will work closely with colleagues to support the development, qualification, and commercialization of innovative medical devices and associated software.
Key Responsibilities:- Provide software quality leadership for new product introductions and sustaining product development teams.
- Work closely with software development teams on process optimization for efficient iterative generation and maintenance of regulatory deliverables.
- Support the creation and review of all medical device software documentation including software development plans, design specifications, software safety classification, software design verification testing plans, protocols, and reports, software issue tracking, and resolution, cyber security assessments, etc.
- Develop test plans and test cases based upon the product and component level requirements.
- Ensure that product development projects and changes to existing products are conducted in compliance with applicable regulations and standards, and internal company procedures.
- Lead the creation and review of risk management files to include the risk management plan, product hazard analysis, FMEA's, risk management matrix, and benefit risk determination.
- Bachelor's degree or higher in a related field.
- At least 3 years of experience in a regulated work environment, including at least 2 years in medical devices.
- Technical expertise with strong communication skills.
- Experience with verification and validation (V&V) required.
- Expert knowledge of IEC 62304 (Software Development Life Cycle).
- Good working knowledge of ISO13485 and ISO14971.
For further details, please contact us directly.
