On site position working with TN visa with advanced English level and Medical devices industry experience. Must have availability to live in California.San Jose, California, U.S.As a Software Validation Engineer, you will play a crucial role in ensuring the reliability and compliance of software used in our medical devices. You will be responsible for planning, executing, and documenting software validation activities according to industry standards and regulatory guidelines. This role requires strong analytical skills, attention to detail, and experience in software validation processes for the medical devices industry.Key Responsibilities:Develop and implement software validation plans, protocols, and reports in accordance with regulatory standards (e.G., FDA 820, CFR Prt 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.Qualifications and Skills: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: Ability to configure and validate software integrations, particularly Maximo, ensuring compliance with maintenance and calibration requirements for medical devices.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.Advanced EnglishPreferred Qualifications:Certification in software quality or validation, such as CSQE (Certified Software Quality Engineer) or CQA (Certified Quality Auditor).Provide training and support to team members on software validation processes and best practices.#J-18808-Ljbffr
