Ausbildung Fachinformatiker Systemintegration bei Axians, Köln. Planung, Konfiguration und Integration von IT - Systemen mit individueller Förderung.
About the role
- Systems Engineer V&V managing verification and validation activities in medical device development at Insulet. Responsible for leading system engineering for verification and validation in cross-functional teams.
Responsibilities
- Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products.
- Develop detailed Verification and Validation Plans for assigned projects
- Collaborate with Systems Engineering in Systems Engineering COE to ensure that all requirements are testable
- Create and document novel and robust test methodologies
- Analyze design changes implemented after execution of verification and validation to determine regression testing required
- Provide technical consulting and mentoring in areas of expertise to early-career members of the Design Verification test team
- Perform systemic reviews of test cases to ensure complete coverage of typical use and edge cases scenarios
Requirements
- Bachelors’ Degree in Biomedical Engineering, Software Engineering, Systems Engineering, Computer Science, Electrical Engineering or a related field.
- Minimum of 3 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 1+ years of experience
- Strong technical judgement with extensive technical leadership skills
- Familiarity with System Level Testing of software based Medical Devices
- Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, ISO 14971 and ISO 9000
- Familiarity with the story design and the use of Atlassian Tools (JIRA, Confluence, Bamboo) in the software development process.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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