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Software Design Assurance Specialist

vor 2 Monaten


Waldbronn, Deutschland Agilent Vollzeit

About the Role

Agilent is seeking a highly skilled Software Design Assurance Specialist to join our team. As a key member of our Design Quality Group, you will play a critical role in ensuring the quality and reliability of our software solutions.

Key Responsibilities

  • Provide guidance and expertise on product development and change control to R&D, marketing, procurement, and production teams.
  • Ensure data, product, and process quality, and provide oversight of design controls, risk management, and verification and validation activities.
  • Review software documentation and test results, including deviations and defects, and take corrective actions as needed.
  • Ensure compliance to Agilent's quality management system and external standards, such as ISO 9001 and ISO 13485.
  • Participate in project meetings and design reviews, risk management activities, design transfer, and other quality-related initiatives.
  • Support the development and maintenance of test automation and regression test suites.
  • Define metrics to assess software attributes, such as size, complexity, code coverage, and system performance.
  • Provide input to verification and validation studies and own, review, and approve design control deliverables and changes.
  • Act as a subject matter expert for software defects or critical issues affecting health and safety.

Requirements

  • Bachelor's or Master's degree in software engineering, business informatics, or equivalent.
  • 4 years of relevant experience in product development and/or quality engineering using waterfall and agile methodologies.
  • Experience with ISO 9001, ISO 13485, and/or ISO 62304, as well as relevant cybersecurity standards and data integrity compliance.
  • Hands-on experience with test automation infrastructure, coding languages (TypeScript, C#, JavaScript, Python, VB Script), and system architecture designs.
  • Understanding of software project lifecycles, test processes, and tools (JIRA), and ISTQB certification.
  • Experience with laboratory equipment in the genomics field and quality requirements for medical devices and data integrity compliance.
  • Ability to communicate and understand biological and clinical applications.

About Agilent

Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise.

Equal Opportunity Employer

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected categories under all applicable laws.