Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Senior Scientist, IVD Product Development
San Carlos, CA · On-site
$138K - $172K/yr
Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Senior Scientist, IVD Product Development
San Carlos, CA · On-site
$138K - $172K/yr
Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Senior Scientist, IVD Product Development
San Carlos, CA · On-site
$138K - $172K/yr
Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Quick apply
Senior Scientist, IVD Product Development
San Carlos, CA · On-site
$138K - $172K/yr
Experience with IVD product development and design controls K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry underlying nucleic acid extraction, PCR, NGS library preparation ...
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
Staff Scientist, IVD Product Development
San Carlos, CA · On-site
$157K - $196K/yr
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
Staff Scientist, IVD Product Development
San Carlos, CA · On-site
$157K - $196K/yr
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
Staff Scientist, IVD Product Development
$157K - $196K/yr
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
Quick apply
Staff Scientist, IVD Product Development
$157K - $196K/yr
Experience with IVD product development and design controls * Deep technical knowledge of NGS biology and processes K NOWLEDGE, SKILLS, AND ABILITIES: * Strong understanding of the chemistry ...
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 ...
Quick apply
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 ...
IVD Laboratory Technician
$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 ...
IVD Laboratory Technician
$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 ...
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 ...
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 ...
End-to-end product management , leading cross-functional teams ( R&D, marketing, sales, regulatory ... Qualifications: * 5+ years of experience in IVD or core laboratory diagnostics , with product ...
End-to-end product management , leading cross-functional teams ( R&D, marketing, sales, regulatory ... Qualifications: * 5+ years of experience in IVD or core laboratory diagnostics , with product ...
Senior Scientific Expert IVD
Germantown, MD · On-site
$82K - $137K/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 ...
Senior Scientific Expert IVD
Germantown, MD · On-site
$82K - $137K/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 ...
Assess and qualify new suppliers in product development and throughout the product lifecycle. * Establish and maintain Design History File for IVD products * Establish, monitor and analyze quality ...
Quick apply
Assess and qualify new suppliers in product development and throughout the product lifecycle. * Establish and maintain Design History File for IVD products * Establish, monitor and analyze quality ...
Responsible for overseeing RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products. * Works closely with ...
Responsible for overseeing RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products. * Works closely with ...
Staff Quality Engineer- Pharma and Diagnostics
Marlborough, MA · Hybrid
$55.94 - $59.44/hr
* This role ensures that IVD products meet stringent regulatory requirements and quality standards. * The Staff Quality Engineer will lead quality engineering initiatives, support product development ...
Quick apply
Staff Quality Engineer- Pharma and Diagnostics
Marlborough, MA · Hybrid
$55.94 - $59.44/hr
* This role ensures that IVD products meet stringent regulatory requirements and quality standards. * The Staff Quality Engineer will lead quality engineering initiatives, support product development ...
Responsible for overseeing RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products. * Works closely with ...
Responsible for overseeing RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products. * Works closely with ...
Staff Quality Engineer - Pharma & Diagnostics
Marlborough, MA · On-site
$74K - $96K/yr
Assess and qualify new suppliers in product development and throughout the product lifecycle. Establish and maintain Design History File for IVD products Establish, monitor and analyze quality ...
Staff Quality Engineer - Pharma & Diagnostics
Marlborough, MA · On-site
$74K - $96K/yr
Assess and qualify new suppliers in product development and throughout the product lifecycle. Establish and maintain Design History File for IVD products Establish, monitor and analyze quality ...
Senior Assay Development Consultant / Contractor POC IVD Clinical Chemistry
Monmouth Junction, NJ · On-site
$93K - $127K/yr
S.-based assay development and product development capabilities while advancing next-generation POC ... We are seeking an experienced POC IVD Assay Development Consultant / Contractor to support and ...
Quick apply
Senior Assay Development Consultant / Contractor POC IVD Clinical Chemistry
Monmouth Junction, NJ · On-site
$93K - $127K/yr
S.-based assay development and product development capabilities while advancing next-generation POC ... We are seeking an experienced POC IVD Assay Development Consultant / Contractor to support and ...
... required for IVD product registration, , and solve and coordinate the difficult problems ... development process of various technology platforms within the company * Product life cycle ...
... required for IVD product registration, , and solve and coordinate the difficult problems ... development process of various technology platforms within the company * Product life cycle ...
Regulatory Manager- IVD and 510(k)
San Diego, CA · On-site
$90K - $150K/yr
... on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure ...
Quick apply
Regulatory Manager- IVD and 510(k)
San Diego, CA · On-site
$90K - $150K/yr
... on product development projects to ensure compliance from concept to commercialization. · Review and provide input on product labeling, promotional materials, and change controls to ensure ...
Analytical Chemist &ndash
Des Plaines, IL · On-site
Knowledge of design control and risk management in the context of IVD product development. * Prior experience supporting 510(k) or PMA submissions is a plus
Quick apply
Analytical Chemist &ndash
Des Plaines, IL · On-site
Knowledge of design control and risk management in the context of IVD product development. * Prior experience supporting 510(k) or PMA submissions is a plus
Ivd Product Development information
See salary details
$42.5K - $51.8K
1% of jobs
$51.8K - $61K
0% of jobs
$61K - $70.3K
2% of jobs
$70.3K - $79.6K
3% of jobs
$79.6K - $88.9K
4% of jobs
$88.9K - $98.1K
4% of jobs
$98.1K - $107.4K
4% of jobs
$113.8K is the 25th percentile. Wages below this are outliers.
$107.4K - $116.7K
9% of jobs
$116.7K - $126K
6% of jobs
$126K - $135.2K
2% of jobs
The median wage is $137.2K / yr.
$135.2K - $144.5K
64% of jobs
$42.5K
$127K
$144.5K
How much do ivd product development jobs pay per year?
What is the difference between Ivd Product Development vs Ivd Quality Assurance?
| Aspect | Ivd Product Development | Ivd Quality Assurance |
|---|---|---|
| Primary Focus | Designing and developing in vitro diagnostic products | Ensuring the quality and compliance of IVD products |
| Required Credentials | Engineering or scientific degrees, regulatory knowledge | Quality management certifications, regulatory standards familiarity |
| Work Environment | Research labs, product design teams | Quality labs, regulatory compliance departments |
| Industry Usage | Product creation and innovation | Product validation, testing, and compliance assurance |
While Ivd Product Development focuses on creating and designing new diagnostic products, Ivd Quality Assurance ensures these products meet quality standards and regulatory requirements. Both roles are essential in bringing safe and effective IVD products to market, often working closely throughout the product lifecycle.

Other
Posted 22 days ago
Natera rating
7.7
Based on 35 frontline employees who took The Breakroom Quiz
47th of 103 rated laboratories
Job description
POSITION SUMMARY:
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 Senior Scientist with a strong focus on reagent and process optimization 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 Senior 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 run in a commercial CLIA laboratory
- Manage assigned technical projects and associated timelines and deliverables in NGS-based assays. Mentor and manage the functional activities of junior employees
- Design and execute moderate to high complexity experiments and perform basic data analysis (e.g. JMP, R, 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 operators on protocols.
- Lead 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
- May manage Research Associates
QUALIFICATIONS:
- BA/BS with 8+ years experience, MS with 5+ years or PhD with 3+ 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
- Data analysis (JMP) 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)