Verification Lead for Systemic Design Verification

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The Position

The RDS R&D POC (Point of Care) department develops diagnostic systems used for the measurement of various physiological parameters in the hospital and critical care environment. We provide solutions for on-the-spot diagnosis in the areas of coagulation monitoring, urinalysis, glucose management, cardiovascular care and blood gas & electrolyte (BG/E) testing. The team comprises experts with various backgrounds in engineering, physics, chemistry, biology, and laboratory.

As part of our POC instrument development team, we are looking for an ambitious verification lead for systemic design verification. This is an excellent opportunity to join a dynamic and motivated, international multi-site team, which supports product care and new development projects in an interdisciplinary environment.

THE OPPORTUNITY

• Development of testing concepts and strategies for design verification incl. software-, hardware-, workflow testing and accountability for the test execution
• Reviewing requirement and specification documentation to ensure clarity and testability; defining test cases based on requirements, risk ratings and complexity as well as selection of appropriate testing methods
• Providing verification and defect management deliverables (project- and system specific documentation compliant with internal and FDA / IVDR guidelines) and status reporting to respective stakeholders in the project team
• Maintaining and documenting testing tools according to internal computerized system validation processes as well as lab equipment/instruments according internal equipment management processes
• Defect management including preparing and leading the defect review board, monitoring defect analysis and implementation as well as coordinating defect retesting
• Ensuring adherence to relevant stipulation documents, best practices and working instructions

WHO YOU ARE

You bring the following profile and competencies:

• Masters degree in electronic, mechanical, software or medical engineering with a focus on design verification / testing (at least 3 -5 years of experience in this domain); ISTQB certification is a plus
• Experience of leadership in a matrix setting and the ability to lead interdisciplinary projects
• Influencing, inspiring and enthusiastic team player with excellent communication and collaboration skills
• Strong technical background combined with problem solving skills and a “will-do” attitude
• Good verbal and written English is needed and German is a plus

If you are an experienced engineer looking for an opportunity to create impact in a highly complex project, we would love to hear from you.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.