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ABC Industries, Inc.

IVD Value Stream Lead

Akron, IN · On-site

The Value Stream Lead is responsible for overseeing and working alongside the IVD department and its team members. This individual will monitor production and quality control on all materials ...

Natera

OR

As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to ...

Axiom Talent Platform

OR · On-site

$309K/yr

We are seeking an experienced FDA Regulatory Attorney with deep, hands-on expertise in Class III PMA in vitro diagnostic (IVD) and companion diagnostic products to work with our client, a Fortune 500 ...

Natera

Lead Biostatistician (IVD Clinical)

$130K - $163K/yr

As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to ...

Natera

Lead Biostatistician (IVD Clinical)

San Carlos, CA · On-site

$144K - $180K/yr

As a Lead Biostatistician, you will leverage your strong applied statistics and IVD expertise to oversee the design, analysis, and interpretation of clinical trials for regulatory submissions to ...

Quanterix

Sr. Director, Assay Development

Billerica, MA

$225K - $265K/yr

D setting (IVD/Diagnostics), including design, development, and verification/validation activities supporting commercialization. * 5+ years of experience managing people and leading immunoassay ...

Quanterix

Senior Regulatory Specialists

Billerica, MA · On-site +1

$115K - $133K/yr

This role will be responsible for IVD product submissions, clinical protocol review and product labeling review. What You'll Do: * Preparation and timely completion of FDA submissions for in vitro ...

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How much do ivd jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for ivd in the United States is $49.70, according to ZipRecruiter salary data. Most workers in this role earn between $32.69 and $59.62 per hour, depending on experience, location, and employer.

What are the typical daily responsibilities of an IVD specialist?

An IVD Specialist is typically responsible for performing and analyzing laboratory diagnostic tests using specialized instruments and assays, ensuring that all procedures comply with quality and regulatory standards. Daily tasks often include calibrating equipment, troubleshooting technical issues, documenting results, and collaborating closely with clinicians or laboratory staff to interpret findings. The role may also involve maintaining records for regulatory audits and participating in ongoing training to stay current with technological advancements. By providing reliable test results, IVD Specialists play a crucial role in supporting patient care and clinical decision-making.

What are the key skills and qualifications needed to thrive in the IVD position, and why are they important?

To thrive as an IVD (In Vitro Diagnostics) Specialist, you need a solid background in medical laboratory sciences, biochemistry, or a related life science field, often supported by a relevant degree. Familiarity with diagnostic instruments, laboratory information management systems (LIMS), and regulatory standards such as ISO 13485 is essential. Strong attention to detail, communication skills, and the ability to problem-solve in a fast-paced setting are key soft skills in this role. These competencies are crucial for ensuring diagnostic accuracy, regulatory compliance, and effective collaboration across multidisciplinary healthcare and laboratory teams.

What is an IVD?

An IVD (In Vitro Diagnostics) job involves developing, testing, and regulating diagnostic tests used to detect diseases, conditions, or infections from biological samples outside the human body. Professionals in this field work in research, regulatory affairs, quality control, and manufacturing to ensure accuracy, reliability, and compliance with industry standards. IVD specialists are employed by medical device companies, clinical laboratories, and regulatory agencies.

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Ivd jobs near you
Infographic showing various Ivd job openings in the United States as of August 2026, with employment types broken down into 93% Full Time, 2% Part Time, 1% Temporary, and 4% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $103,383 per year, or $49.7 per hour.

Staff Design Control Engineer, Design Quality (IVD/CDx/Medical Device))

Quest Diagnostics

Marlborough, MA • On-site

$105K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 7 days ago

ExamOne rating

6.6

Company rating: 6.6 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

97th of 120 rated laboratories

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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