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Ivd Medical Device Jobs (NOW HIRING)

... medical device, IVD, or reagent manufacturing environment. * Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820. * Experience developing ...

... medical device, IVD, or reagent manufacturing environment. * Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820. * Experience developing ...

Sr. QC Manager

Waltham, MA · On-site

$150 - $170/hr

... medical device, IVD, or reagent manufacturing environment. * Strong working knowledge of ISO 13485, ISO 14971, MDSAP, IVDR, and FDA regulations including 21 CFR Part 820. * Experience developing ...

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 ...

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 ...

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 ...

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 ...

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Ivd Medical Device information

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$49

$96

How much do ivd medical device jobs pay per hour?

As of Aug 14, 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:

Infographic showing various Ivd Medical Device job openings in the United States as of August 2026, with employment types broken down into 45% Full Time, and 55% Contract. Highlights an 100% In-person job distribution, with an average salary of $103,662 per year, or $49.8 per hour.

Medical Device Reliability and Design Engineer

Tunnell Government Services

Bethesda, MD

$109K - $138K/yr

Full-time

Posted 3 days ago

New


Job description

Duties & Responsibilities:

  • Serve as a scientific and technical representative to the DHHS Contracting Officer (CO) and Program Officer (PO) (or COTR, as applicable) concerning IVD product development spanning:
    • advanced development,
    • development, verification, and validation under a Quality Management System
    • regulatory filings and processes leading to FDA clearance,
    • reliable, robust, and scalable commercial manufacturing.
  • Review and give expert analysis regarding documents generated by BARDA contractors and federal employees for scientific / technical correctness and regulatory compliance. These include reviewing design documents such as requirements, project plans, usability reports, design for manufacturing considerations, project risk analysis, product hazard analysis, and others.
  • Render technical / regulatory compliance opinions to the PO / CO / COTR.
  • Actively participate in meetings with federal and contractor employees to obtain and evaluate project status and progress against contract milestones. 
  • Where/when required, perform site visits with PO/CO (COTR or other designated representative) to contractor facilities, and/or facilities of subcontractors, to verify compliance with contract requirements, federal regulations and guidelines.
  • Inform PO/CO/COTR of any increase/decrease in risk to success of the project and generate contingency risk reduction plans.   
  • Prepare draft statements of work (SOW)/statements of objectives (SOO) for Requests for Proposals (RFP). 
  • Assist in contract negotiations on scientific / technical matters as requested, including reviewing proposed SOW.
  • Use extensive technical and industry knowledge to provide insight and technical counsel concerning BARDA's strategic position within the medical device / diagnostics developmental and manufacturing communities.
  • Independently perform activities consistent with established organizational practices, precedents, policies and strategic objectives set forth by BARDA management.
  • Review incoming white papers and proposals

Requirements:

  • A Masters or equivalent in mechanical, electrical, systems, biomedical engineering, or closely related scientific disciplines is required.  
  • 15 or more years of industry experience in one or more of the following areas:
    • IVD product development, with specific experience and accomplishments in diagnostics testing, from concept through commercialization.
    • FDA diagnostic and medical device clearances, approvals, and licensures.
    • Diagnostic device development expertise
    • Design and development of both instruments and cartridges
    • Microfluidic design, development, and troubleshooting
    • Plastics engineering / design for molding, specifically for cartridges
  • The successful candidate may have government and/or academic accomplishments, but those are secondary to actual IVD industry experience.
  • Substantial IVD advanced development skills should be demonstrable. 
  • Substantial skills in IVD process manufacturing should be demonstrable.
  • Working familiarity with FDA current Good Manufacturing Practices (cGMP) is a plus.
  • Working experience with Design Control, Quality Systems Management, and ISO 13485 principles is essential

Travel Requirements - up to 10%

Must be a US Citizen or Full Green Card holder.