Senior Systems Engineer

Role: Senior Systems Engineer responsible for overseeing the full lifecycle of IVD instrument development and commercialization at Quanterix. Objectives include ensuring regulatory compliance, risk management, analytical validation, and supporting product release. Responsibilities encompass risk documentation (FMEA, hazard analysis), design review support, field failure analysis, and authoring design control and validation reports for regulated diagnostics. Qualifications: Bachelor's in Mechanical, Electrical, or related Engineering with 10+ years (or Master's with 7+ years) experience in IVD or life sciences instrument development, with proven FDA/ISO design control expertise, including DHF authoring for cleared products. Preferred skills: hands-on immunoassay platform experience, risk management proficiency per ISO 14971, regulatory documentation skills, EMC/EMI testing familiarity, and knowledge of international regulatory pathways (e.g., CE marking). High-value specifics: expertise with immunoassay platforms, regulatory standards (FDA 21 CFR Part 820, ISO 13485), and experience with analytical validation aligned to CLSI guidelines; exposure to ultra-sensitive biomarker technologies, single-molecule detection, and DFM/DFA for electromechanical systems. Collaboration involves R&D, Quality, Regulatory, and Commercial teams. Work setup: on-site in Billerica, MA with 10% travel; physical capacity to lift 40 lbs. The role emphasizes cross-functional influence, structured problem-solving, and communication skills, supporting Quanterix’s advanced biomarker and spatial biology platforms.