Verification And Validation Engineer (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Verification and Validation Engineer (Medtech): Ensuring software requirements and system designs for medical device products are verified through structured testing with an accent on regulatory compliance and quality standards. Focus on developing comprehensive test protocols, executing V&V activities, and coordinating with cross-functional teams to ensure safe and reliable product releases.
Location: Onsite in Brisbane, Australia (Fortitude Valley)
Company
An innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for orthopedics and patient care.
What you will do
- Develop, execute, and maintain V&V test plans, protocols, and reports for software and system-level requirements.
- Review product specifications and design documentation to create comprehensive test cases.
- Perform hands-on software verification and validation for new product development and enhancements.
- Identify software defects, investigate root causes, and collaborate with development teams for troubleshooting.
- Participate in Agile ceremonies, including daily stand-ups and sprint planning.
- Support regulatory submissions by providing detailed V&V documentation.
Requirements
- Bachelor's degree in Biomedical, Software, Computer, or Electrical Engineering, or Computer Science.
- 2–3 years of experience in software V&V, software quality assurance, or medical device development.
- Experience working within regulated industries, preferably medical devices.
- Strong knowledge of the software development lifecycle (SDLC) and V&V methodologies.
- Proven technical writing and organizational skills for documenting test results.
Nice to have
- Experience in Agile software development environments.
- Familiarity with FDA 21 CFR Part 820, IEC 62304, and ISO 13485 standards.
- Understanding of software architecture concepts and design patterns.
- Experience with requirements management and defect tracking tools.
- Knowledge of musculoskeletal anatomy and orthopedic devices.
Culture & Benefits
- Culture focused on continuous improvement, scientific excellence, and innovation.
- Collaborative environment working across global talent and cross-functional teams.
- Opportunity to contribute to technology that directly improves patient outcomes.
- Commitment to equal employment opportunity and diversity.
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