In Vitro Diagnostics Scientist

We are seeking an In Vitro Diagnostics Scientist to develop surface immunoassays and be a core member of our engineering team. The candidate will join a multi-disciplinary team dedicated to developing high-quality products. The ideal candidate is a team player, likes overcoming difficult challenges, enjoys learning new skills, and has a “hands-on” problem solving approach. This is an outstanding opportunity for a self-motivated individual to make a key contribution and increase their responsibilities in a high-growth start-up environment.

Job responsibilities:
As part of the 1DROP team, the candidate will develop diagnostic assays on the biosensor platform and will be expected to perform the following:
• Take ownership of the development, optimization and commercialization of a range of diagnostic assays.
• Functionalize diagnostic chips using surface modifications, deposition of capture reagents, detection reagents, and analytes, passivation from non-specific binding.
• Characterize the developed assays using blood and serum samples and statistical analysis (sensitivity, specificity, accuracy).
• Assist in writing technical requirements, design specifications, verification test plans and reports, and risk management plans.

Our ideal candidate:
• Bachelor, Master or PhD degree in biomedical engineering, biomaterials, molecular biology, biochemistry, life sciences or related field.
• Experience integrating biological reagents (proteins, nucleic acids) with medical devices
• Experience developing IVD assays and developing medical devices.
• Understand the requirements for manufacturable devices and associated processes.
• Demonstrated record of achievement and professional maturity in a corporate environment.
• Excellent planning and problem solving skills.
• Ability to balance multiple assignments simultaneously.
• Effective communication skills and ability to communicate with all levels of the organization.

Nice to have skills and experience:
• Product development experience using and working with many of the following: microfluidics, molecular biology techniques including, biophotometer, fluorescence microscopy, protein and DNA microarrays.
• Optimization and characterization of surface chemistry for biological systems.
• Experience depositing proteins on surfaces using microarray spotters such as Arrayit, Bio-Rad, Agilent, Sonoplot.
• Biological inkjet printers such as MicroDrop, GeSiM, Scienion.
• Statistical analysis tools such as R, Julia, Python.
• Experience working with a quality system in a regulated industry, preferably medical diagnostics or medical devices.