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Core Lab Development (CLD), a part of Roche Diagnostics Solution (RDS), is the global organization responsible for the development of tests in the area of clinical and immunochemistry, coagulation, and mass spectrometry, and the related analytic systems. In addition, the Core Lab focuses on the development of laboratory automation, including transport systems, pre- and post-analytical systems, and the integration of these systems into comprehensive solutions.
As an important component of this mission, the Solution Automation Integration & Test (SAIT) Subchapter ensures the seamless integration and testing of our Automation Systems and End-to-End Solutions. We are seeking a System Integration & Testing Project Lead to join our highly skilled, multi-cultural team and take a central role in ensuring the robust functioning of our pre- and post-analytical systems, transport systems, and their connectivity and compatibility with our solutions.
As the System Integration & Testing Project Lead, you will drive the verification and validation (V&V) strategy to ensure our hardware and software product functions meet the highest quality standards.
Project Leadership: Plan, coordinate, and document requirements and acceptance test campaigns (preliminary & final) while fostering matrix leadership and technical coaching for testing teams.
V&V Strategy: Define cross-functional HW/SW product functions and maintain accountability for the verification process compliance, implementation of standards, and all V&V deliverables.
Backlog & Planning: Manage and prioritize the Team/Product Backlog using Agile methodologies (SAFe/Scrum) and define testing acceptance criteria in collaboration with stakeholders.
Design & Risk Management: Review requirements for testability, perform system design verification, and assess system-level product risks to ensure alignment with the Solution architecture.
Execution & Traceability: Monitor progress across test campaigns, managing deviations and ensuring strict traceability between system requirements, design, and validation records.
Resource Management: Accountable for the planning and commissioning of necessary test equipment and environments, alongside budget monitoring for all design verification activities.
Stakeholder Collaboration: Bridge the gap between technical engineering teams and non-technical stakeholders, including external OEM partners, to ensure seamless system integration.
You are an experienced engineer passionate about automation, possessing the technical depth and leadership skills required to navigate complex, regulated MedTech environments.
Education & Experience: University degree in Engineering or Natural Sciences with 5+ years of experience in medical device development (IVD preferred) and a proven track record in hardware-centric integration.
Technical Expertise: Strong ability to define complex engineering work packages, manage formal design verification (V&V), and maintain compliance within highly regulated environments.
Agile Proficiency: Deep knowledge of Agile frameworks (SAFe/Scrum/Kanban) specifically applied to physical product development constraints like tooling and BOM lead times.
Communication & Collaboration: Exceptional communication skills in English (German and Asian culture communication are advantages), with the ability to influence and negotiate effectively.
Mindset: A self-organized, responsible team player who is open-minded, enthusiastic about continuous process optimization, and capable of dealing with complex, high-pressure situations.
Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
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Roche is an Equal Opportunity Employer.