Senior Systems Engineer

Senior Systems Engineer Billerica, MA Role Summary The Senior Systems Engineer is a senior individual contributor responsible for providing deep technical expertise across the full lifecycle of IVD instrument development and commercialization. This role sits at the intersection of engineering rigor, regulatory compliance, and field excellence, supporting activities that span risk management, analytical validation, document authorship, and project management. The ideal candidate brings a strong track record of building and releasing IVD instruments under FDA/ISO design controls, firsthand immunoassay platform experience, and technical versatility to lead both lab‑bench validation work and field deployment activities. This is a highly cross‑functional role requiring collaboration with R&D, Quality, Regulatory, and Commercial teams. What You'll Do Lead and maintain risk management documentation (FMEA, Hazard Analysis, Risk Benefit Analysis) in accordance with ISO 14971 throughout the product lifecycle. Identify, assess, and mitigate technical risks associated with instrument design, reagent‑instrument interface, and clinical use scenarios. Support design review processes by providing risk‑informed input across mechanical, electrical, optical, and software subsystems. Evaluate field failure data and complaint trends to drive corrective and preventive actions (CAPAs) back into design and risk files. Author, review, and maintain design control documentation including System Requirements Specifications (SRS), Design Input/Output documents, Verification & Validation (V&V) protocols, and summary reports. Maintain Design History File (DHF) completeness and traceability matrices across hardware, software, and consumable design elements. Draft and revise SOPs, work instructions, test methods, service bulletins, and engineering change orders (ECOs) in compliance with QMS requirements. Produce clear, technically rigorous reports suitable for regulatory submissions (510(k), PMA supplements, CE Technical Files). Design and execute analytical validation studies including precision, accuracy, linearity, interferent studies, and method comparison for immunoassay‑based assays and instrument platforms. Apply CLSI guidelines (EP05, EP06, EP09, EP15, EP17) and relevant IVD standards to study design and data interpretation. Collaborate with reagent development and assay teams to characterize reagent‑instrument interactions and define release specifications. Generate and defend analytical validation packages in support of regulatory submissions and customer site qualifications. Basic Qualifications Bachelor’s Degree in Mechanical, Electrical, or a related Engineering discipline with 10+ years experience Master’s Degree in Mechanical, Electrical, or a related Engineering discipline with 7+ years experience Progressive experience in IVD or life sciences instrument development, with a demonstrated record of building and commercially releasing regulated diagnostic instruments. Deep expertise in FDA 21 CFR Part 820 and ISO 13485 design control frameworks; direct experience authoring DHF deliverables for cleared or approved IVD products. Preferred Qualifications Hands‑on Immunoassay platform experience (HD‑X, SP‑X, or equivalent single‑molecule array technology) in a development or applications context. Proven proficiency in risk management per ISO 14971, including FMEA facilitation and hazard analysis authorship. Strong technical writing skills with demonstrated ability to produce regulatory‑grade reports and design control documentation. Experience with EMC/EMI compliance testing, test laboratories, and familiarity with IEC 61010, IEC 61326, FCC Part 15, and applicable IVD EMC standards. Experience with CE marking (IVDR 2017/746) and international regulatory submissions in addition to US 510(k)/De Novo pathways. Background in usability engineering per IEC 62366‑1, including formative and summative studies. Exposure to single‑molecule detection, immunoassay development, or related ultra‑sensitive biomarker measurement technologies. Experience with manufacturing transfer, DFM/DFA, and production readiness reviews for complex electromechanical systems. Proficiency in Python, MATLAB, or equivalent for data analysis, test automation, or instrument control. Expectations, Competencies, Skills & Abilities Strong cross‑functional collaboration and influencing skills Structured problem‑solving and sound engineering judgment Systems‑level thinking across hardware, software, and assay interactions Strong project planning, prioritization, and execution skills Ability to communicate complex technical concepts clearly to diverse audiences Skill in synthesizing data into clear conclusions and actionable recommendations Ability to identify risks early and elevate issues appropriately Ability to work independently and lead through influence in matrixed environments Adaptability and sound judgment in a fast‑paced, regulated environment Continuous improvement mindset with strong attention to detail and quality Workplace location: Billerica, MA (On‑site) Travel 10 % Must lift 40 lb (if applicable) Diverse & Inclusive Workplace Quanterix is a Diverse and Inclusive workplace and will hire individuals who demonstrate an inclusive mindset. Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. #J-18808-Ljbffr Quanterix