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Ivd Medical Device Jobs (NOW HIRING)

CorDx

IVD Laboratory Technician

Alpharetta, GA · On-site

$18.50 - $24.75/hr

... care medical device solutions used in the detection of infectious diseases such as COVID-19 ... Support various stages of the IVD product design and development process , from feasibility and ...

BSI Group

Medical Device QMS Auditor

Concord, NC · Remote

$98K - $123K/yr

Minimum of 4 years' experience in the medical device, SaMD, or IVD fields with direct, hands-on involvement in designing, manufacturing, validating, inspecting, testing, or clinically evaluating ...

CorDx

IVD Laboratory Technician

Alpharetta, GA

$18.50 - $24.75/hr

... care medical device solutions used in the detection of infectious diseases such as COVID-19 ... 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

... care medical device solutions used in the detection of infectious diseases such as COVID-19 ... Support various stages of the IVD product design and development process , from feasibility and ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000 ...

CorDx

Regulatory Manager- IVD and 510(k)

San Diego, CA · On-site

$90K - $150K/yr

... care medical device solutions used in the detection of infectious disease such as COVID-19 ... Regulatory Manager - IVD and 510(K) Location: Onsite - San Diego Salary Range: $90000-$150000 ...

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How much do ivd medical device jobs pay per hour?

As of Jun 11, 2026, the average hourly pay for ivd medical device in the United States is $49.84, according to ZipRecruiter salary data. Most workers in this role earn between $35.10 and $59.62 per hour, depending on experience, location, and employer.

What are IVD Medical Devices?

IVD Medical Devices, or In Vitro Diagnostic Medical Devices, are tools and equipment used to analyze samples such as blood, urine, or tissue taken from the human body. These devices help detect diseases, monitor health conditions, and guide treatment decisions by providing information about a person's health. Common examples include blood glucose meters, pregnancy tests, and laboratory reagents. IVDs play a critical role in disease prevention, diagnosis, and management in both clinical and home settings.

What are some common challenges faced by professionals working in the IVD Medical Device industry, and how can they be addressed?

Professionals in the IVD Medical Device field often face challenges related to stringent regulatory requirements, rapid technological advancements, and the need for cross-functional collaboration. Navigating evolving regulations can be complex, so staying updated with global standards (such as FDA and EU IVDR) is crucial. Additionally, working closely with R&D, quality assurance, and regulatory teams helps ensure that devices meet both compliance and market needs. Continuous learning and proactive communication are key strategies for overcoming these challenges and driving successful product development.

What are the key skills and qualifications needed to thrive as an IVD Medical Device Specialist, and why are they important?

To thrive as an IVD Medical Device Specialist, you need a strong background in biomedical sciences, regulatory compliance, and quality assurance, often supported by a degree in life sciences or engineering. Familiarity with ISO 13485, FDA regulations, CE marking, and laboratory diagnostic equipment is typically required, along with certifications like RAC or Six Sigma being advantageous. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for collaborating with cross-functional teams and ensuring product safety. These competencies are crucial for maintaining regulatory standards, ensuring product efficacy, and supporting patient health outcomes.

What is the difference between Ivd Medical Device vs Medical Laboratory Technician?

AspectIvd Medical DeviceMedical Laboratory Technician
CertificationsRegulatory approvals, quality assuranceASCP certification, state licensure
Work EnvironmentManufacturing, quality control, R&DLaboratories, hospitals, clinics
Industry UsageMedical device manufacturing, diagnosticsClinical testing, sample analysis

While both roles are involved in the healthcare industry, Ivd Medical Device professionals focus on the development, regulation, and quality assurance of in vitro diagnostic devices, often working in manufacturing or R&D settings. Medical Laboratory Technicians perform clinical testing and sample analysis in laboratory environments. Understanding these differences helps clarify career paths and industry roles.

More about Ivd Medical Device jobs
What cities are hiring for Ivd Medical Device jobs? Cities with the most Ivd Medical Device job openings:
What states have the most Ivd Medical Device jobs? States with the most job openings for Ivd Medical Device jobs include:
What job categories do people searching Ivd Medical Device jobs look for? The top searched job categories for Ivd Medical Device jobs are:
Ivd Medical Device jobs near you
Infographic showing various Ivd Medical Device job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, and 25% Contract. Highlights an 100% In-person job distribution, with an average salary of $103,662 per year, or $49.8 per hour.
Principal Device Quality Engineer - IVD devices SME (JP9691-S)

Principal Device Quality Engineer - IVD devices SME (JP9691-S)

3 Key Consulting

South San Francisco, CA • On-site

Other

Posted 12 days ago

Job description


Job Title: Principal Device Quality Engineer - IVD devices SME(JP9691-S)
Location: Thousand Oaks, California OR San Francisco, California OR Cambridge, Massachusetts
Employment Type: Contract
Business Unit: Digital Health & Diagnostics Quality
Duration: 12 months with likely extensions
Job posting date: 1/20/2022
Note: Remote until Covid restrictions are lifted.
3 Key Consulting is hiring a Principal Device Quality Engineer - IVD devices SME for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Manager is open to candidates working remotely until restrictions are lifted
  • Candidates must have 5+ years working with IVD devices. Must be IVD subject matter expert.
  • This key role in the Quality organization will assist with the co-development, commercialization, and lifecycle management for diagnostic and companion diagnostic devices (IVD's) to support the client therapeutics.
  • The role will be highly visible, interacting with cross-functional internal European and U.S. management and technical team members, and multiple IVD manufacturers, to prepare for and execute activities including manufacturer due diligence and evaluation, manufacturer auditing, design control, inspection readiness and lifecycle management.
  • The position will report to a member of the Device Quality department leadership team and provide thought leadership and current best practices surrounding considerations and continued development of internal processes related to control of IVDs. The staff member will report to the Corporate Quality function at the Thousand Oaks, California headquarters.
  • Train and educate key functional partners and management on regional and international IVD requirements, standards and regulations
  • Suggest and participate in improvements to the quality system, particularly related to IVDs
  • Provide Quality leadership for regulatory interactions for IVDs
  • Review and approve procedures and work Instructions
  • Specifically, this role will employ quality principles and company's procedures including but not limited to the areas of Purchasing Controls, Design Controls, Change Controls and NC/CAPA, Risk Management, Human Factor Engineering, Process Validation, and Manufacturing and Distribution, to ensure co-development and sustainment of IVD products complies with applicable regulations and standards. Such devices may include (but are not limited to):
    • IVDs intended to diagnose a condition client's therapeutics treat
    • IVDs intended for client drug titration
    • IVDs intended to monitor a condition client's therapeutics treat

Basic Qualifications
  • Doctorate degree and 2 years of directly related experience OR
  • Master's degree and 6 years of directly related experience OR
  • Bachelor's degree and 8 years of directly related experience OR
  • Associate's degree and 10 years of directly related experience OR
  • High school diploma / GED and 12 years of directly related experience

Preferred Qualifications
  • BS in Science/Engineering - preferably chemistry, biology, software, mechanical, or electrical engineering.
  • 5+ years of Quality, Engineering or Operations experience in the IVD medical device industry
  • Experience with quality systems including: 21 CFR 820, European Medical Device Directives (MDD) and Medical Device Regulations (MDR), IEC 62304, ISO 13485, ISO 14971, IEC 62366.
  • Knowledge of Medical Device Design Controls, particularly for in vitro devices. Experience working in in vitro device development, manufacturing or validation function is a plus.
  • Experience with designing and executing IVD clinical trials is a plus, particularly as part of a co-development agreement between a biopharmaceutical manufacturer and an IVD manufacturer
  • Experience in interacting with notified bodies and regulatory agencies in an inspection setting for In Vitro devices.
  • Strong project management skills including the ability to manage multiple workflows simultaneously and work within business processes as well as quality management systems
  • Ability to work in a cross-functional team environment and to influence personnel across functions and at all levels
  • High personal integrity with a positive attitude and a strong work ethic
  • Experience in driving improvement and implementing change
  • Demonstrated the ability to effectively work independently and with individuals located in remote locations
  • Inter-personal skills and demonstrated ability to teach lay staff quality principles

Top Must have Skill Sets:
  • Audits / inspections / quality agreements (purchasing controls)
  • Quality or Technical experience within a GMP regulated IVD manufacturer (IVDD, IVDR, FDA QSR)
  • Ability to teach high performing staff who have a device quality background, but not necessarily IVD experience

Employee Value Proposition:
Compelling, active and growing area of interest and innovation within precision medicine
Ability to gain experience from the "pharma" side of IVD and companion diagnostics
Broad exposure to many innovative IVD manufacturers
Red Flags:
  • No or minimal practical experience for IVD manufacturers
  • "Consultant" view, rather than "executor" view. We need people to do actual work, not give advice on policy and strategy
  • Poor communicator

Interview Process:
Initial phone screen followed by 3 or 4 behavioral interviews (combined, 1 day).
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that you're not interested in pursuing this position, please feel free to look at other positions on our websitewww.3keyconsulting.com. You are welcome to also sharethis posting withanyone you think might be interested in applying for this role.

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