About this role
Senior Systems Engineer at Quanterix. Location: Billerica, Massachusetts, United States. Role: managing risk, authoring documentation, conducting validation Requirements: Experience building and commercializing IVD instruments under FDA/ISO design controls, strong risk management and analytical validation expertise, technical writing, and 7+ years engineering experience (Master's) or 10+ years (Bachelor's). Category: Engineering Seniority: Senior Level Tools: Python, MATLAB, Simoa, PhenoCycler, PhenoImager Fusion, PhenoImager HT, PhenoCode Panels, ISO 14971, FDA 21 CFR Part 820, ISO 13485, CLSI EP05, CLSI EP06, CLSI EP09, CLSI EP15, CLSI EP17, IEC 61010, IEC 61326, IEC 62366-1, IVDR 2017/746, FCC Part 15 Commitment: Full Time Workplace: Onsite Languages: English