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Software Validation Engineer III
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BEPC Incorporated is seeking a highly skilled Software Validation Engineer III to join our team in San José, California. As a key member of our engineering team, you will play a crucial role in ensuring the reliability and compliance of software used in our medical devices.
Key Responsibilities- Develop and Implement Software Validation Plans: Create and execute software validation plans, protocols, and reports in accordance with regulatory standards, such as FDA 820, CFR Part 11, and ISO 13485.
- Collaborate with Cross-Functional Teams: Work closely with cross-functional teams to define software requirement specifications and ensure alignment with validation activities.
- Perform Risk Assessments: Conduct risk assessments to ensure that all software components meet the required safety, performance, and compliance criteria.
- Conduct Software Testing: Perform software testing, including unit, integration, system, and acceptance testing, to verify and validate software functionality.
- Document Validation Activities: Document all validation activities, including deviations and corrective actions, to ensure traceability and compliance with regulatory requirements.
- Bachelor's Degree in Engineering: Bachelor's degree in Mechanical, Software, Industrial, or Biomedical Engineering, or a related field. A Master's degree is a plus.
- Software Validation Experience: Minimum of 3-5 years of experience in software validation within the medical devices industry.
- Knowledge of IBM Maximo: Knowledge and implementation experience with IBM Maximo or similar systems, including configuration and validation of software integrations, particularly Maximo, ensuring compliance with maintenance and calibration requirements for medical devices.
- Strong Analytical Skills: Strong analytical and problem-solving skills, with attention to detail.
- Excellent Communication Skills: Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
- Agile Methodologies: Experience with Agile methodologies and tools.
- Software Development Lifecycle: Familiarity with software development lifecycle (SDLC) processes and tools.
- Advanced English: Advanced English language skills.
- Certification in Software Quality: Certification in software quality or validation, such as CSQE (Certified Software Quality Engineer) or CQA (Certified Quality Auditor).
- Training and Support: Provide training and support to team members on software validation processes and best practices.
