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QUANTERIX CORP

IVD Process Engineer

Billerica, MA · On-site

$150K - $180K/yr

IVD Process Engineer Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary ...

Quanterix

IVD Process Engineer

Billerica, MA

$150K - $180K/yr

IVD Process Engineer Billerica, MA Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary ...

ABC Industries Inc

IVD Generalist

Winona Lake, IN

Production & Assembly Operate the Roto Heat Sealer to heat seal tubing and other IVD products. Perform sewing tasks to seal tubing and assemble industrial ventilation ducting. Manufacture various ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Support various stages of the IVD product design and development process , from feasibility and prototyping through verification and validation. * Collaborate with R&D, Quality, and Regulatory teams ...

Qiagen

Senior Scientific Expert IVD

Germantown, MD

$82K - $137K/yr

The ideal candidate will have experience in developing in vitro diagnostic (IVD) products in a regulated environment. A strong background in immunology/molecular biology is critical. The Senior ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Support various stages of the IVD product design and development process , from feasibility and prototyping through verification and validation. * Collaborate with R&D, Quality, and Regulatory teams ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Support various stages of the IVD product design and development process , from feasibility and prototyping through verification and validation. * Collaborate with R&D, Quality, and Regulatory teams ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities • Prepare and submit 510(k) applications for IVD products to ensure timely ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000/Yearly Responsibilities · Prepare and submit 510(k) applications for IVD products to ensure timely ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

The ideal candidate will have a strong background in IVD (In Vitro Diagnostics) and experience with 510(k) preparation and submissions to ensure compliance with FDA and other regulatory body ...

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How much do ivd jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for ivd in the United States is $49.70, according to ZipRecruiter salary data. Most workers in this role earn between $32.69 and $59.62 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an IVD Specialist?

An IVD Specialist is typically responsible for performing and analyzing laboratory diagnostic tests using specialized instruments and assays, ensuring that all procedures comply with quality and regulatory standards. Daily tasks often include calibrating equipment, troubleshooting technical issues, documenting results, and collaborating closely with clinicians or laboratory staff to interpret findings. The role may also involve maintaining records for regulatory audits and participating in ongoing training to stay current with technological advancements. By providing reliable test results, IVD Specialists play a crucial role in supporting patient care and clinical decision-making.

What are the key skills and qualifications needed to thrive in the Ivd position, and why are they important?

To thrive as an IVD (In Vitro Diagnostics) Specialist, you need a solid background in medical laboratory sciences, biochemistry, or a related life science field, often supported by a relevant degree. Familiarity with diagnostic instruments, laboratory information management systems (LIMS), and regulatory standards such as ISO 13485 is essential. Strong attention to detail, communication skills, and the ability to problem-solve in a fast-paced setting are key soft skills in this role. These competencies are crucial for ensuring diagnostic accuracy, regulatory compliance, and effective collaboration across multidisciplinary healthcare and laboratory teams.

What is an IVD job?

An IVD (In Vitro Diagnostics) job involves developing, testing, and regulating diagnostic tests used to detect diseases, conditions, or infections from biological samples outside the human body. Professionals in this field work in research, regulatory affairs, quality control, and manufacturing to ensure accuracy, reliability, and compliance with industry standards. IVD specialists are employed by medical device companies, clinical laboratories, and regulatory agencies.

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Ivd jobs near you
Infographic showing various Ivd job openings in the United States as of May 2026, with employment types broken down into 81% Full Time, 16% Contract, and 3% Nights. Highlights an 89% In-person, and 11% Remote job distribution, with an average salary of $103,383 per year, or $49.7 per hour.
IVD Process Engineer

IVD Process Engineer

QUANTERIX CORP

Billerica, MA • On-site

$150K - $180K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

Job description

IVD Process 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:
We are looking for an experienced and motivated candidate to join our Process Development team. In this critical role, this individual will drive the development and deployment of our IVD reagent supply and manufacturing processes, from the lab bench through to production scale. You will design and execute experiments and drive innovations to continuously advance process characterization and scale up methodology in an FDA-regulated environment. You will identify technical requirements in our products, define appropriate methods, and work with internal and external stakeholders to enable a sustainable reagent operations process.
WHAT YOU'LL DO:
  • Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development.
  • Define requirements and documenting process for IVD and RUO products.
  • Deploy analytical test systems in collaboration with Research, Technology and Reagent R&D, Technical Operations and Quality to characterize and qualify reagent components.
  • Implement reagent product manufacturing processes, including formulation, filling/finishing, and packaging processes for both IVD and RUO products.
  • Continuously improve the reagent manufacturing including supplier technical support, process development and implementation. Includes working with suppliers on consumables.
  • Facilitate root cause analysis and ideation of the improvement opportunities from the metric discussions.

BASIC QUALIFICATIONS:
  • BS in molecular biology, biochemistry, chemistry, or engineering. 15+ years of experience.
  • MS in chemistry/biology technology disciplines as above, with 12+ years of experience.
  • PhD in chemistry/biology technology disciplines as above, with 8+ years of experience.
  • 5+ years of experience in product and process development.

PREFERRED QUALIFICATIONS:
  • Experience in IVD and/or RUO product and process development
  • Experience developing reagent manufacturing processes in a regulated environment
  • Knowledge of reagent formulation, fill/finish, and packaging processes
  • Experience with process characterization, qualification, and scale-up
  • Familiarity with analytical test methods for reagent/component evaluation
  • Experience supporting manufacturing operations and process transfer
  • Knowledge of biomolecule diagnostics or related assay technologies
  • Experience partnering cross-functionally with R&D, Operations, Quality, and suppliers
  • Strong root cause analysis and continuous improvement skills
    Advanced degree in molecular biology, biochemistry, chemistry, or engineering preferred

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:
  • IVD/RUO reagent process development
  • Process characterization and analytical methods
  • Reagent formulation and scale-up
  • FDA-regulated product/process development
  • Technical problem solving and troubleshooting
  • Root cause analysis and process optimization
  • Manufacturing process transfer and implementation
  • Biomolecule diagnostic systems knowledge
  • Demonstrated technical expertise as well as management experience.
  • Significant experience in product and process development.
  • Experience in biomolecule diagnostics is ideal.
  • Both small/large-scale project/process experience and manufacturing operations experience.
  • Individuals applying for this position must be self-starters, flexible in changing direction and methods and thrive in a fast-paced environment
  • Workplace location: Billerica, MA
  • Travel 10%
  • Must lift 25 amount pounds (if applicable)

WHY YOU'LL LIKE WORKING WITH US:
Our Technology:
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.
Pay Range: $150,000 - $180,000 per year

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