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Software Validation Engineer
hace 2 meses
Bepc Incorporated is seeking a highly skilled Software Validation Engineer to join our team. As a key member of our medical devices team, you will play a crucial role in ensuring the reliability and compliance of software used in our products.
Key Responsibilities:- Develop and implement software validation plans, protocols, and reports in accordance with regulatory standards (e.g., FDA 820, CFR Part 11, ISO 13485).
- Collaborate with cross-functional teams to define software requirement specifications and ensure alignment with validation activities.
- Perform risk assessments and ensure that all software components meet the required safety, performance, and compliance criteria.
- Conduct software testing, including unit, integration, system, and acceptance testing, to verify and validate software functionality.
- Document all validation activities, including deviations and corrective actions, to ensure traceability and compliance with regulatory requirements.
- Bachelor's degree in Mechanical, Software, Industrial, or Biomedical Engineering, or a related field. A Master's degree is a plus.
- Minimum of 3-5 years of experience in software validation within the medical devices industry.
- Knowledge and implementation experience with IBM Maximo or similar systems.
- Strong knowledge of FDA regulations, GAMP 5, ISO 13485, and other relevant medical device software standards.
- Experience in writing and executing software validation documents, protocols, and reports.
- Strong analytical and problem-solving skills, with attention to detail.
- Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
- Experience with Agile methodologies and tools.
- Familiarity with software development lifecycle (SDLC) processes and tools.
- Ability to manage multiple projects and priorities in a fast-paced environment.
- Certification in software quality or validation, such as CSQE (Certified Software Quality Engineer) or CQA (Certified Quality Auditor).
Bepc Incorporated is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
