Senior Systems Engineer

Senior Systems Engineer

Billerica, MA

Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades.

In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue-advancing precision medicine from discovery to diagnostics.

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, 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 the 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…