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Director Ivd Product Development Jobs (NOW HIRING)

Natera

Scientist, IVD Product Development

San Carlos, CA · On-site

$116K - $146K/yr

Experience with IVD product development and design controls. Knowledge, Skills, and Abilities: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Support various stages of the IVD product design and development process , from feasibility and ...

CorDx

IVD Laboratory Technician

Alpharetta, GA

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Support various stages of the IVD product design and development process , from feasibility and ...

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

Execute routine and non-routine testing to support product development, verification, validation ... Support various stages of the IVD product design and development process , from feasibility and ...

Qiagen

Senior Scientific Expert IVD

Germantown, MD · Hybrid

$82K - $120K/yr

The Senior Scientific Expert will join the QIAGEN Germantown R&D Team in research and development of innovative products to support and strengthen the IVD immunoassay portfolio. The ideal candidate ...

Mastech Digital

Software V&V Engineer

San Diego, CA · On-site

... IVD Product Development and IVD Product Testing. Essential Duties and Responsibilities Design and execute test protocols to verify requirements and design specifications, ensuring conformance to ...

New

CorDx

Program Director

San Diego, CA

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

CorDx

Program Director

Atlanta, GA

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

CorDx

Program Director

Atlanta, GA · On-site

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

CorDx

Program Director

Atlanta, GA · On-site

Program Director Location: Onsite - Atlanta/San Diego Job Overview: We are seeking a highly skilled ... IVD) and broader diagnostics portfolio. This role will oversee complex product development ...

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Director Ivd Product Development information

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$73K

$163.7K

$244.5K

How much do director ivd product development jobs pay per year?

As of Aug 29, 2026, the average yearly pay for director ivd product development in the United States is $163,684.00, according to ZipRecruiter salary data. Most workers in this role earn between $131,500.00 and $185,500.00 per year, depending on experience, location, and employer.

What does a director IVD product development do?

A Director of IVD (In Vitro Diagnostics) Product Development leads teams responsible for creating and improving diagnostic devices and assays used in laboratory testing of biological samples. They oversee the entire product development process, from concept through design, testing, regulatory approval, and market launch. Their role involves strategic planning, cross-functional collaboration, ensuring compliance with regulatory standards, and managing timelines and budgets. Directors in this field play a critical role in bringing innovative diagnostic products to market that improve patient care.

What are the key skills and qualifications needed to thrive as a director IVD product development?

To thrive as a Director of IVD Product Development, you need deep expertise in in vitro diagnostics, product lifecycle management, and regulatory requirements, usually supported by an advanced degree in a scientific or engineering field. Familiarity with product development tools, quality management systems (such as ISO 13485), and regulatory submission platforms (like FDA or CE Mark processes) is essential. Strong leadership, strategic thinking, and cross-functional communication skills help drive innovation and align multidisciplinary teams. These skills ensure the successful development and launch of compliant, high-quality diagnostic products that meet market and regulatory demands.

What are some common challenges faced by a director IVD product development and how can they be addressed?

A Director of IVD Product Development often encounters challenges such as navigating complex regulatory requirements, aligning cross-functional teams, and managing tight project timelines. Successfully addressing these challenges requires staying up-to-date with evolving regulations (e.g., FDA, CE marking), fostering clear communication among R&D, regulatory, and marketing teams, and implementing robust project management practices. Building strong relationships with stakeholders and encouraging a culture of transparency can help to anticipate risks early and keep product development on track.

What is the difference between Director Ivd Product Development vs Product Manager Ivd?

AspectDirector Ivd Product DevelopmentProduct Manager Ivd
ResponsibilitiesOversees entire product development teams, strategic planning, and long-term product visionManages specific product features, coordinates cross-functional teams, and executes product plans
Required CredentialsTypically requires advanced degrees and extensive industry experienceOften requires a bachelor's or master's degree with relevant experience
Work EnvironmentLeadership role within R&D or product development departments in medical device companiesCollaborates across engineering, marketing, and regulatory teams in similar settings

The main difference is that the Director Ivd Product Development focuses on strategic leadership and overseeing the entire product development process, while the Product Manager Ivd handles day-to-day product planning and execution. Both roles require industry-specific knowledge and collaboration across teams, but the director has a broader scope and higher level of responsibility.

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Director Ivd Product Development jobs near you
Infographic showing various Director Ivd Product Development job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 83% Full Time, 14% Part Time, and 2% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $163,684 per year, or $78.7 per hour.

Scientist, IVD Product Development

San Carlos, CA

Natera
Biotechnology Research and Development • 1 - 5K employees

7.7

Company rating: 7.7 out of 10

Based on 38 frontline employees who took The Breakroom Quiz

56th of 120 rated laboratories

People enjoy working here

Good employer

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Learn more about Nateraexternal

Full-time

Posted 10 days ago

Job description

Natera is a global leader in cell-free DNA testing. We measure fetal, tumor, or donor cfDNA at the molecular level to help inform personalized health care decisions with a non-invasive test.

We are looking for a highly motivated Scientist with a strong focus on process optimization and product verification studies to join the Early Cancer Detection product development team, joining a group of scientists who are tasked with developing and advancing Natera's oncology product portfolio.

The Scientist will be working with internal cross functional teams to develop IVD products. The ideal candidate is a driven professional who maintains broad knowledge of molecular biology and chemistry, and applies statistical principles to experiment design and analysis. The Scientist should have an in-depth understanding of design control methods and experience with current NGS oncology diagnostics devices. 

We are looking for a meticulous and proactive scientist with experience in both NGS-based assay development under design control and meant for submission to FDA and other regulatory bodies and who can work effectively in a fast-paced environment to ensure that the highest quality clinical assays are developed and launched for our patients.

Primary Responsibilities:

  • Design, develop, and validate automated high-throughput NGS assays that will be submitted to FDA and regulatory bodies, and be run in a commercial single-site IVD CLIA laboratory.

  • Manage assigned technical projects and associated timelines and deliverables in NGS-based assays. Mentor junior employees.

  • Design and execute moderate to high complexity experiments and perform basic data analysis (e.g. JMP, Excel).

  • Collaborate with other assay development scientists on the specifications of assay, reagent, equipment and quality metrics for future production assays.

  • Work with Clinical Laboratory and Quality Assurance to ensure that developed methods meet Natera's rigorous quality standards.

  • Coordinate with multiple internal groups (automation engineering, laboratory operations, bioinformatics, statistics, project and product management) and serve as point person to ensure the successful identification and timely execution of projects.

  • Write project protocols, reports and SOPs and train lab operations clinical lab scientists on procedures.

  • Plan and execute verification activities.

  • Identify areas for continuous improvement and actively contribute to the effort of introducing better practices to improve production workflows and shorten TAT for patient samples.

Minimum Qualifications:

  • BA/BS with 5+ years experience, MS with 3+ years or PhD with 1+ years experience in assay development and automation for the life science industry.  

  • Demonstrated track record of development and validation of automated protocols for CLIA labs.

  • Experience with IVD product development and design controls.

Knowledge, Skills, and Abilities:

  • Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation, and hybrid capture technologies

  • Hands-on experience in reagent preparation and quality control for NGS-based assays

  • Experience implementing, optimizing, and troubleshooting high-throughput automated assays utilizing liquid handler robots

  • Strong individual contributor as well as dedicated team player

  • Experience designing and executing studies including stability, guard banding, reproducibility and repeatability and QC method development

  • Experience working in a regulated laboratory environment under CLIA/CAP

  • Data analysis (JMP and Excel) required, coding skills (Python or R), and liquid handler programming experience are a plus

  • Excellent communication, organizational, record-keeping, planning, attention to detail and time management skills

  • Ability to manage multiple priorities in a fast-paced, dynamic environment and to collaborate cross-functionally with other groups (regulatory affairs, CLIA, LIMS, lab operations QA, automation, research)

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