Senior Systems Engineer

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.

• 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., * 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 escalate 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 amount pounds (if applicable)

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, From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease. Akoya Biosciences, a Quanterix company, is The Spatial Biology Company-bringing tissue context to life through high-resolution, single-cell imaging. Akoya's spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler, PhenoImager Fusion and HT, and PhenoCode Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood. Our Commitment to Employees: At Quanterix, our values are based on: Team, Innovation, Customer and Owner. Team: Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards Innovation: Stay curious, experiment, create and change Customer: Prioritize and celebrate these pioneers by doing our best to deliver on commitments Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures. We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day! DIVERSE & INCLUSIVE WORKPLACE: Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values. 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. Quanterix is committed to a diverse and inclusive workplace. Quanterix is an equal opportunity employer and does not discriminate on the basis of 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.