Verification & Validation Engineer
3 days ago
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Radiometer, one of Danaher s 15+ operating companies, our work saves lives and we re all united by a shared commitment to innovate for tangible impact.
You ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher s system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. As a global leader and pioneer in acute care diagnostics for over 70 years, we streamline diagnostic workflows, empowering healthcare professionals to focus on what truly matters caring for critically ill patients. We re a team that celebrates diverse ideas and continuous improvement. Here, you ll find a place to grow and make a real impact with your unique perspective, driving us forward in improving patient care.
Learn about the Danaher Business System which makes everything possible.
As part of our strategic expansion and increased capacity at our India site, we are establishing a new team and are currently seeking a Verification & Validation Engineer to take on a pivotal role combining technical expertise with team leadership responsibilities.
In this role, you will lead a small team of lab technicians and be accountable for the integration, verification, and system performance validation of Radiometer products. You will also oversee the planning and execution of activities within our dedicated lab facility, ensuring high standards of quality and compliance.
If you are passionate about working with complex systems and bring experience in the verification, validation, and testing of medical devices, this is a unique opportunity to make a significant impact in a dynamic and growing environment.
This position reports to the R&D Director, ACDx Systems Releases Department and is part of the Bangalore Development Center located in Bangalore, India. The role is designated as full-time, on-site.
In this dynamic and impactful role, you will have the opportunity to:
- Collaborate with cross-functional development teams to ensure products meet rigorous performance and compliance standards.
- Design and implement robust verification strategies and plans, balancing quality, risk, and cost-effectiveness.
- Author verification and validation protocols, conduct thorough data analysis, and compile comprehensive reports aligned with global regulatory standards.
- Monitor and follow up on test results, providing timely updates and insights to project managers and leadership.
- Establish and maintain local quality control and assurance procedures in alignment with regional regulatory requirements, in collaboration with RA and QA departments.
- Lead and manage a team of lab technicians, prioritizing and supervising daily activities within the verification and validation lab.
- Work in close coordination with the Verification & Validation teams at headquarters to ensure a seamless transfer of capabilities and best practices.
The essential requirements of the job include:
- 6+ years of work experience in Systems Engineering;
- Work experience in Verification & Validation in Medical devices or in a regulated business;
- Master in bio-chemistry/molecular biology / biotechnology / bioengineering / biomedical engineering or equivalent;
- Good knowledge in statistics and in the use of statistic methods;
Ability to travel:
o ~ 2 months/year to the head quarter in Copenhagen
o To the Radiometer site IDC in Bangalore (1-2 times/month)
It would be a plus if you also possess previous experience in:
- Visual agile planning
- Working with blood in a lab environment
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