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Medical Device Validation Jobs (NOW HIRING)

PCI Pharma Services

Director, Validation

Bedford, NH · On-site

As a member of the Validation organization, the Validation Director will lead pharmaceutical and medical device validation operations and staff across all PCI sites. The scope of responsibility ...

Intellectt INC

Validation Engineer

San Diego, CA · On-site

Strong experience in medical device validation, including IQ/OQ/PQ, process validation, facility/lab qualification, and Excel spreadsheet validation. * Knowledge of FDA 21 CFR 820.30, 21 CFR 820.70 ...

NYTP

Sr. Manual Tester

San Diego, CA

Position: Sr. Consultant with experience in Medical Device validation and 62304 governance standards Location: San Diego, CA Length: Long Term. 100% Onsite position Ensure the quality of the medical ...

Crown Medical, Inc.

Medical Device Rep

Austin, TX · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Baton Rouge, LA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Albuquerque, NM · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Sarasota, FL · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Carlsbad, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Boca Raton, FL · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

Crown Medical, Inc.

Medical Device Rep

Santa Barbara, CA · On-site

$82K - $113K/yr

Medical Sales Territory Representative - Entry Level We are a leading Medical Device and Equipment ... Have a valid driver's license * At least some success with abilities in business-to-business sales;

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All JobsMedical Device Validation Jobs

Medical Device Validation information

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How much do medical device validation jobs pay per hour?

As of Jun 28, 2026, the average hourly pay for medical device validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is medical device validation?

Medical device validation is the process of ensuring that a medical device consistently produces results that meet predetermined requirements and quality standards for its intended use. This involves rigorous testing and documentation to confirm that the device functions safely and effectively under real-world conditions. Validation is a critical step in regulatory approval and helps protect patient safety by verifying the device's performance and reliability. The process typically includes design validation, process validation, and software validation, depending on the type of device.

What are common challenges faced in a Medical Device Validation role and how are they typically addressed?

Professionals in Medical Device Validation often encounter challenges such as ensuring compliance with evolving regulatory standards, managing tight project timelines, and coordinating with cross-functional teams. Addressing these challenges typically involves staying current with industry regulations (like FDA or ISO standards), meticulous documentation practices, and frequent communication with engineering, quality assurance, and manufacturing teams. Proactive problem-solving, flexibility, and a detail-oriented mindset are essential for overcoming barriers and ensuring that devices meet safety and efficacy requirements before market release.

What is the difference between Medical Device Validation vs Quality Assurance Specialist?

AspectMedical Device ValidationQuality Assurance Specialist
CertificationsISO 13485, FDA regulations, Validation protocolsISO 9001, GMP, FDA regulations
Work EnvironmentManufacturing, R&D, Regulatory complianceManufacturing, Quality control, Auditing
Primary FocusEnsuring devices meet specifications through testing and validationMaintaining quality systems and compliance

Medical Device Validation focuses on verifying that devices meet design and performance specifications through testing and validation processes. Quality Assurance Specialists oversee overall quality systems, ensuring compliance with standards and regulations. While both roles aim to ensure product safety and efficacy, Validation is more technical and testing-oriented, whereas QA is broader, covering system-wide quality management.

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

To thrive as a Medical Device Validation Specialist, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA and ISO 13485), and experience in validation protocols. Familiarity with validation tools, statistical analysis software, and documentation systems is typically required, along with certifications like Six Sigma or CQE being advantageous. Strong attention to detail, analytical thinking, and effective communication are crucial soft skills for success in this role. These skills ensure that medical devices meet safety and quality standards, supporting compliance and protecting patient health.
More about Medical Device Validation jobs
What cities are hiring for Medical Device Validation jobs? Cities with the most Medical Device Validation job openings:
What states have the most Medical Device Validation jobs? States with the most job openings for Medical Device Validation jobs include:
What job categories do people searching Medical Device Validation jobs look for? The top searched job categories for Medical Device Validation jobs are:
Medical Device Validation jobs near you
Infographic showing various Medical Device Validation job openings in the United States as of June 2026, with employment types broken down into 4% Locum Tenens, 1% Internship, 25% As Needed, 62% Full Time, 4% Part Time, and 4% Contract. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Medical Device Validation and Verification SME

ConfigUSA

San Diego, CA • On-site

Other

Posted 3 days ago

Job description

Medical Device Validation and Verification SME

Location: San Diego, CA

Duration: 6 months

Preferred Skills

· Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita)

· Exposure to software validation / computerized system validation (CSV)

· Prior experience in large-scale validation programs (100+ protocols)

· Strong documentation and audit readiness experience

· Familiarity with tools like: o TrackWise / Veeva / ETQ (or similar QMS systems) Experience Requirement

· 8–12+ years in V&V within the medical device industry

· Proven experience working as a Subject Matter Expert (SME)

· Prior experience working in onsite client environments in the US is a strong plus

· Expat profiles are acceptable Candidate Profile

· Self-driven and capable of working independently with minimal guidance

· Strong ownership mindset with execution focus

· Excellent communication and stakeholder management skills

· Comfortable working under tight timelines and immediate onboarding expectations

Roles & Responsibilities

 

Role Overview:

We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system. The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training. The candidate will contribute toward executing approximately 150–170 validation protocols within a defined timeline

Key Responsibilities:

· Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)

· Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21CFR Part 820)

· Drive end-to-end protocol lifecycle, including:

o   Protocol authoring

o   Test execution

o   Documentation and reporting

o   Defect tracking and resolution

· Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)

· Provide SME-level inputs for validation strategy and risk-based validation approaches

· Support audit readiness and documentation for regulatory inspections

· Work in a high-paced environment with immediate delivery expectations

Generic Managerial Skills, If any

1. Leadership

2. Communication Skills

3. Stakeholder Management

4. Decision Making

5. Problem Solving

6. Mentoring & Coaching

7. Conflict Resolution

8. Strategic Thinking

9. Time & Priority Management

10. Adaptability & Flexibility

Desirable Skills:

Keyword: Skills: ISO 13485~EIS : Medical Device & Regulations

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