IVD Process Engineer

IVD Process Engineer - Billerica, MA

We are looking for an experienced and motivated candidate to join our Process Development team. In this critical role, you will drive the development and deployment of our IVD reagent supply and manufacturing processes, from lab bench through 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.

• Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development.
• Define requirements and document processes 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 reagent manufacturing, including supplier technical support, process development and implementation, and working with suppliers on consumables.
• Facilitate root‑cause analysis and ideation of improvement opportunities from metric discussions.

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

• 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.

• 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 and 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.
• Self‑starter, flexible in changing direction and methods, thrives in a fast‑paced environment.
• Travel 10% of time.
• Must be able to lift 25 pounds (if applicable).

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.