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Ivd Product Development Jobs (NOW HIRING)

CorDx

Program Director

San Diego, CA

Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. * Develop and manage ...

CYNET SYSTEMS

Staff Quality Engineer

Marlborough, MA · On-site

$55 - $59/hr

Experience supporting IVD products preferred. * Experience conducting hazard analysis and risk ... Collaborate with product development teams to integrate quality requirements into product design ...

CorDx

Program Director

Atlanta, GA

Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. * Develop and manage ...

CorDx

Program Director

San Diego, CA · On-site

Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. * Develop and manage ...

CorDx

Program Director

Atlanta, GA · On-site

Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. * Develop and manage ...

CorDx

Program Director

Atlanta, GA · On-site

Lead cross-functional program teams across R&D, Regulatory Affairs, Clinical, Quality, Operations, and Commercial to deliver IVD/diagnostic products from feasibility to launch. * Develop and manage ...

Werfen

Data Analytics Intern

Norcross, GA · On-site

Overview Job Summary We are seeking a highly motivated Data Analytics Scientist/Intern to support the development of innovative In Vitro Diagnostic (IVD) products for the Transfusion technology ...

Werfen

Data Analytics Intern

Norcross, GA

Overview Job Summary We are seeking a highly motivated Data Analytics Scientist/Intern to support the development of innovative In Vitro Diagnostic (IVD) products for the Transfusion technology ...

Werfen

Data Analytics Intern

Norcross, GA · On-site

Overview Job Summary We are seeking a highly motivated Data Analytics Scientist/Intern to support the development of innovative In Vitro Diagnostic (IVD) products for the Transfusion technology ...

QUANTERIX CORP

IVD Process Engineer

Billerica, MA · On-site

$150K - $180K/yr

Develop reagent processes and collaborate with Research, Technology and Reagent R&D on IVD and RUO product development. * Define requirements and documenting process for IVD and RUO products.

Werfen

Data Analytics Intern

Norcross, GA · On-site

Overview Job Summary We are seeking a highly motivated Data Analytics Scientist/Intern to support the development of innovative In Vitro Diagnostic (IVD) products for the Transfusion technology ...

Predicine, Inc

Head of Manufacturing

Hayward, CA · On-site

... , QA/RA, and supply chain teams. Key Responsibilities: Manufacturing Leadership & Strategy • Develop and execute manufacturing strategies that support the growth of the IVD/NGS product portfolio ...

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All JobsIvd Product Development Jobs

Ivd Product Development information

See salary details

$42.5K

$127K

$144.5K

How much do ivd product development jobs pay per year?

As of Jun 11, 2026, the average yearly pay for ivd product development in the United States is $126,987.00, according to ZipRecruiter salary data. Most workers in this role earn between $114,500.00 and $143,000.00 per year, depending on experience, location, and employer.

What is the difference between Ivd Product Development vs Ivd Quality Assurance?

AspectIvd Product DevelopmentIvd Quality Assurance
Primary FocusDesigning and developing in vitro diagnostic productsEnsuring the quality and compliance of IVD products
Required CredentialsEngineering or scientific degrees, regulatory knowledgeQuality management certifications, regulatory standards familiarity
Work EnvironmentResearch labs, product design teamsQuality labs, regulatory compliance departments
Industry UsageProduct creation and innovationProduct 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.

What are the most commonly searched types of Ivd Product Development jobs? The most popular types of Ivd Product Development jobs are:
Infographic showing various Ivd Product Development job openings in the United States as of June 2026, with employment types broken down into 79% Full Time, 17% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $126,987 per year, or $61.1 per hour.
Staff Engineer, Design Quality (CDx/FDA)

Staff Engineer, Design Quality (CDx/FDA)

Quest Diagnostics

Marlborough, MA • On-site

$105K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 11 days ago

ExamOne rating

6.2

Company rating: 6.2 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

88th of 103 rated laboratories

Job description

Job Description
Pay Range: $105,000.00 - $125,000.00 / year
Salary offers are based on a wide range of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual performance bonus compensation.
Benefits Information:
We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in all respects - physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits offered may include:
• Day 1 Medical, supplemental health, dental & vision for FT employees who work 30+ hours
• Best-in-class well-being programs
• Annual, no-cost health assessment program Blueprint for Wellness®
• healthyMINDS mental health program
• Vacation and Health/Flex Time
• 6 Holidays plus 1 "MyDay" off
• FinFit financial coaching and services
• 401(k) pre-tax and/or Roth IRA with company match up to 5% after 12 months of service
• Employee stock purchase plan
• Life and disability insurance, plus buy-up option
• Flexible Spending Accounts
• Annual incentive plans
• Matching gifts program
• Education assistance through MyQuest for Education
• Career advancement opportunities
• and so much more!
The Staff Design Quality Engineer is a highly experienced technical quality leader responsible for quality oversight of complex IVD medical device development programs, high-risk changes, and technically demanding validation and design transfer activities.
This role applies advanced judgment to product quality, risk, and compliance decisions and serves as a senior subject matter expert for design controls, risk management, validation strategy, design changes, and development documentation.
The role routinely influences program direction, mentors others, and helps resolve the most difficult technical quality issues.
Responsibilities
  • Serve as a senior design quality subject matter expert for complex IVD product development and lifecycle programs involving significant technical, regulatory, or cross-functional complexity.
  • Provide authoritative review and approval of key design control deliverables, including design and development plans, requirements, risk files, validation strategies, design reviews, traceability matrices, and transfer packages within delegated authority.
  • Guide cross-functional teams in translating customer, user, clinical, laboratory, manufacturing, and regulatory requirements into complete and verifiable design inputs and robust design outputs.
  • Lead quality evaluation of major design changes, platform expansions, assay updates, labeling or usability changes, and transfer activities, ensuring impacts are fully assessed and documented.
  • Provide senior-level quality oversight of analytical and clinical validation programs, including review of scientific rationale, protocol quality, deviation investigations, data review approach, and final evidence package sufficiency.
  • Lead or advise on complex investigations, CAPAs, nonconformance assessments, and risk-based decisions involving technical uncertainty or product safety/performance concerns.
  • Drive improvement of design quality processes, templates, training content, and governance mechanisms to strengthen consistency, traceability, and inspection readiness.
  • Represent Design Quality during internal audits, regulatory inspections, partner/customer interactions, and design review governance forums.
  • Mentor design quality and development personnel and provide expert consultation to management on difficult technical quality matters.
  • Support management review by elevating systemic quality risks, adverse trends, and opportunities for improvement across the development portfolio.

Qualifications
Required Work Experience:
  • 8+ years of progressive experience in design quality, development quality, or quality engineering within medical device or IVD environments.
  • Deep technical acumen in design controls, risk management, verification/validation, design transfer, and lifecycle change control for complex IVD products.
  • Demonstrated ability to independently make and defend difficult technical quality decisions using sound regulatory and scientific judgment.
  • Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and associated product development documentation expectations.

Preferred Work Experience:
  • Experience with complex IVD platforms, companion diagnostics, software-enabled systems, or multi-site development programs.
  • Experience supporting external customer or partner-facing development programs, including pharma collaborations.
  • Lead auditor or advanced risk management training.
  • Experience in multi-line or multi-site IVD manufacturing environments and in organizations with significant regulatory visibility or remediation demands.
  • Professional certification in quality or auditing is a plus.

Physical and Mental Requirements:
  • Strong attention to detail for thorough documentation to ensure consistency in documentation.
  • Excellent problem-solving skills to identify and address quality issues effectively.
  • Ability to manage multiple projects to meet deadlines while maintaining accuracy.

Knowledge:
  • Strong working knowledge of FDA QMSR, ISO 13485, ISO 14971,GMP, and practical application of risk-based quality system management.

Skills:
  • Demonstrates strong technical judgment and an ability to apply regulatory and quality requirements to real operational decisions.
  • Communicates clearly across technical and non-technical stakeholders and maintains high standards for documentation quality.
  • Balances speed, compliance, and product quality without compromising patient safety, product performance, or regulatory expectations.
  • Leads with accountability, develops talent, and creates an operating environment that is disciplined, responsive, and audit ready.

Travel required
Education:
  • Bachelor's degree in Engineering, Life Sciences, or related technical field; advanced degree strongly preferred. (Required)

About the Team
Quest Diagnostics honors our service members and encourages veterans to apply.
While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.

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