We are looking for a motivated R&D Scientist/Engineer to join our multidisciplinary product development team. This position combines two complementary missions: system verification & validation and assay & reagent development. You will contribute to verification and validation of systems that integrate biology, microfluidics, hardware, optics, and software as well as the optimization of innovative molecular biology assays (digital PCR).
This role is ideal for a scientist or engineer eager to develop strong expertise in molecular assay development while also gaining exposure to system-level testing and regulatory requirements in the medical device field.
Key Responsibilities:
Verification & Validation (V&V) of Systems and Assays
* Design and execute verification and validation protocols for instruments, consumables, assays, and reagents.
- Collect, analyze, and interpret performance data to ensure products meet quality, regulatory, and customer requirements (ISO 13485, IVDR).
* Collaborate with cross-functional experts (biology, engineering, optics, software, operations) to define test strategies, perform troubleshooting, and support risk analyses.
* Contribute to sustaining engineering, post-market activities, and continuous improvement of V&V methodologies.
Assay & Reagent Development
* Design, perform, and analyze R&D experiments for new reagent formulations and digital PCR assays (product pipeline and custom assay development services).
* Contribute to troubleshooting, optimization, and innovation in assay design.
- Keep up to date with cutting-edge genomics and molecular biology techniques and translate them into product improvements.
* Document experimental work and contribute to writing/updating laboratory protocols and development procedures.
Meet Gwilherm, R&D Engineer
Meet Allison, PhD, Director of R&D Molecular Biology