Responsible for defining the future direction of FMI’s portfolio of offerings for Biopharma partners and accelerating opportunities to pull-through FMI’s solutions across the drug development value chain.

• Direct responsibility for technical validation of changes (hardware, software) to Quanterix' instruments and management of scientists to execute test methods• Develop a deep understanding of Quanterix' customer segments (Biopharma, CRO, Academia) and their specific needs• Coordinate across company functions to ensure the holistic development of new instruments and the extension of existing platforms• Provide strategic direction and voice of customer feedback within Engineering to inform usability and design of new systems• Partner with contract manufacturer and software developers to ensure mutual success throughout product lifecycle• Develop system reliability and usability roadmaps through analysis of field performance data, external partner management for independent assessments, and internal studies interrogating user and system issues• Operate as a key technical contributor on cross-functional development teams

• Achieving financial targets for the Simoa instrument and software portfolio• Lead customer experience vision, strategy, and portfolio development roadmap• Provide thought leadership and work collaboratively with internal and external partners, including Market Communication, Sales and Service & Support• Communicate compelling product concepts, requirements, constraints to senior management and stakeholders• Collaborate closely with cross functional business teams to execute the product roadmap and achieve successful commercialization• Product lifecycle management including product development, launch, maintenance, and discontinuation• Monitor the competitive landscape, identify opportunities and threats to our business• Monitor, understand and identify key customer needs and define opportunities for growth

• Serve as technical lead for new assay development projects through all phases of development, including: definition, concept, design, verification and validation • Represent assay team in all technical meetings and cross-functional, phase gate reviews• Ensure all assay work is carried out in accordance with QMS requirements and conformance to required design control regulations• Author new assay QMS documentation, including Device Master Records, manufacturing procedures and labeling for all assay components• Effectively collaborate in a cross-functional, matrixed team environment to develop appropriate product specifications, review voice of customer material and prepare for design transfer to manufacturing• Lead process excellence initiatives within assay development through the implementation of new procedures and revision of existing processes

• Support the design and development of new immunoassay products on the Simoa platform, a bead-based ELISA technology• Lead development and optimization experiments of new assays for use on automated and semi-automated platform• Present key technical findings to assay development team• Perform required data analyses and summaries to support assay technical and phase gate reviews• Routinely perform antibody conjugations for multiple projects in support of antibody pair screening and development testing• Serve as assay development representative in routine quality monitoring meetings

• Serve as R&D technical lead and provide support for projects with pharma partners for the development of in-vitro assays that will deliver Class II/III IVD devices to market. • Design of IHC and ISH based assays following customer needs to assess suitability for purpose of use and compatibility with the Leica BOND Automated Advanced Staining Platform• Develop, facilitate and lead experimental plans to optimize biomarker specific assays for use on the BOND-III to include: antibody/probe concentration, antigen retrieval/enzymatic digestion methods, detection system reagent incubation, and reducing non-specific signal• Devise and manage milestone driven plans for product development, optimization and verification and validation of new class II/III products following the APD process• Coordinate and manage product/service delivery with a variety of internal/external vendors to maintain consistent, on-time delivery of associated project tasks. • Author and review R&D relevant portions of clinical study protocols to support Clinical Operations• Further support Clinical Operations by conducting site initiation visits at clinical trial sites and provide technical and clinical protocol training to site staff

• Evaluate GYN and NON-GYN specimen for adequacy, abnormalities, malignancy, and disease• Correlate patient history with findings and refer results to pathologist• Prepare slides for screening using ThinPrep slide processor and automated staining platform• Collaborate with colleagues and pathologists to solve difficult cases

• Handling, receiving, sorting, and ordering tests on a variety of patient specimens including: stool, urine, blood, sputum, wound cultures (including sterile bodily fluids), fungal cultures, and throat cultures• Answering queries and solving problems of patients, coworkers,nurses, and doctors over the phone and through email

Relief Mission: 50 hours• Screen conventional gynecological Pap slides for atypia and malignancy; approx 25 slides/day • Perform quality control of screened slides• Develop skills required to screen difficult cases in a population of high disease incidence• Evaluate concordance between technologists' results and remote pathologist's diagnoses