Senior Systems Engineer

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must preserve all substantive info. Remove boilerplate like EEO, etc. Must not include filler like "commensurate with experience". Must not create Pay/Schedule/Benefits unless posting actually states them. Let's see if posting mentions Pay, Schedule, Benefits. It mentions "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!" That's benefits. So Benefits section should be included. Pay: Not explicitly stated. No salary range. So we should NOT include Pay section. Schedule: It mentions "workplace location: Billerica, MA (On-site) Travel 10% Must lift 40 amount pounds (if applicable)". That's location, travel, physical requirement. Not schedule like hours. Could we treat location as part of About the role? Not schedule. No explicit schedule like full-time, part-time, shift. So we should NOT include Schedule section. Now we need sections: About the role (maybe from ROLE SUMMARY). Responsibilities (What You’ll Do). Requirements (Basic Qualifications). Qualifications (Preferred Qualifications). Skills (Expectations, Competencies, Skills & Abilities). Benefits (Why you'll like working with us). Also maybe include a short paragraph for workplace location etc. Could be part of About the role or separate? The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should follow those headings exactly. For content not fitting those, we could embed in About the role or maybe not create extra sections. The location and travel could be placed in About the role as prose. We must preserve all substantive information. So we need to include details: company description, role summary, responsibilities list, basic qualifications, preferred qualifications, expectations/competencies, benefits details. We must not include boilerplate: EEO, diversity statement, etc. Also remove duplicated lines, cookie/navigation/legal/EEO etc. The posting includes a Diverse & Inclusive Workplace section; that's EEO boilerplate; we should remove it. Also remove "WHY YOU’LL LIKE WORKING WITH US:" heading but we will use Benefits heading. We must not repeat job title as heading. The job title is Senior Systems Engineer; we should not output that as heading. We must not put Job ID/requisition numbers as headings; none present. We must output only HTML fragment, no /, no markdown fences. Let's structure:

About the role

... company description and role summary ...

Responsibilities

• ... each bullet ...

Requirements

• ... basic qualifications ...

Qualifications

• ... preferred qualifications ...

Skills

• ... expectations, competencies, skills & abilities ...

Benefits

• ... benefits ...

We need to ensure we preserve all substantive info. Let's extract. Company description: "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: "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." We can combine into About the role paragraph(s). Responsibilities list: "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." We need to split into list items. Each sentence could be a bullet. Requirements (Basic Qualifications): "Bachelor's Degree in Mechanical, Electrical, or a related Engineering discipline with 10+ years experienceMaster's Degree in Mechanical, Electrical, or a related Engineering discipline with 7+ years experienceProgressive 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." We need to parse: It seems two alternatives: Bachelor's with 10+ years OR Master's with 7+ years. Then progressive experience etc. Then deep expertise etc. We'll make bullets. Preferred Qualifications: list items: "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." Skills (Expectations, Competencies, Skills & Abilities): list: "Strong cross-functional collaboration and influencing skillsStructured problem-solving and sound engineering judgmentSystems-level thinking across hardware, software, and assay interactionsStrong project planning, prioritization, and execution skillsAbility to communicate complex technical concepts clearly to diverse audiencesSkill in synthesizing data into clear conclusions and actionable recommendationsAbility to identify risks early and escalate issues appropriatelyAbility to work independently and lead through influence in matrixed environmentsAdaptability and sound judgment in a fast-paced, regulated environmentContinuous improvement mindset with strong attention to detail and quality" We need to split into bullets. Benefits: list items from "WHY YOU’LL LIKE WORKING WITH US:" section: "Our Technology ..." Actually that's more about technology; but benefits include: competitive compensation and a 401k plan with employer match, competitive health, dental, and vision benefits for employees and their dependents, unlimited vacation policy for exempt employees, generous PTO policy for non-exempt employees, eligibility for equity, employee stock purchase plan, performance bonus, 1:1 financial counseling/planning, Tuition Assistance, free state-of-the-art onsite fitness center, free snacks and drinks daily. Also maybe mention "Our Technology" is not a benefit but could be part of About the role? It's more about company tech; but we already have company description. Could include as part of About the role? Might be redundant. However we must preserve all substantive info; we could include a brief paragraph about technology in About the role or maybe a separate section? But we only have allowed headings; we could add a paragraph under About the role describing technology. That would preserve it. Thus About the role will include company description, role summary, and maybe technology description. Let's craft About the role paragraph(s):

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.

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.

That covers. Now Responsibilities bullets: We'll split each sentence. Let's list: - Lead and maintain risk management documentation (FMEA, Hazard Analysis