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Medical Device Validation Jobs (NOW HIRING)

Ensure all changes to equipment and processes meet medical device validation and quality standards and are properly documented. * Maintain strong, open communication with cross-functional teams to ...

Draft validation protocols and reports. * Conduct test method validations. * Support equipment qualification activities. * Troubleshoot laboratory systems. * Execute test scripts. * Maintain ...

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;

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;

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;

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 ...

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;

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;

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;

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;

Medical Device Coder

Carmel, IN · On-site

$17.75 - $23.75/hr

Ensure accuracy of codes applied to devices using data audits, validations and reviews. * Updates ... Evaluates medical device content to ensure the accuracy of HCPCS mappings. * Follows up with ...

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Medical Device Validation information

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$22

$51

$78

How much do medical device validation jobs pay per hour?

As of Jul 19, 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:
Infographic showing various Medical Device Validation job openings in the United States as of July 2026, with employment types broken down into 75% Full Time, 18% Part Time, and 7% Contract. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.
Validation Engineer (Medical Device)

Validation Engineer (Medical Device)

Scalable Systems

San Diego, CA • On-site

Other

Posted 24 days ago


Job description

Scalable Systems is a USA based Big Data, Analytics and Digital Transformation company focused on vertical specific innovative solutions. By providing next generation technology solutions and services, we help organizations to identify risks & opportunities, achieve operational excellence and to gain an innovative edge.

Job Role – Validation Engineer (Medical Device)
Location – San Diego, CA (Day 1 Onsite)

Role Descriptions: Must Have Technical/Functional Skills

Must-Have Skills

· Strong expertise in V&V for medical devices

· Hands-on experience in:

o Protocol writing (IQ, OQ, PQ, CSV, system validation)

o Validation execution and reporting

· Deep understanding of:

o FDA regulations (21 CFR Part 820)

o ISO 13485 standards

o Risk management (ISO 14971)

· Experience in regulated environments with minimal supervision

· Ability to independently manage multiple protocols simultaneously

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, 21 CFR 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 Experience Required: 10 & Above

Scalable Systems is an Equal Opportunity-Affirmative Action Employer - Minority / Female / Disability / Veteran / Gender Identity / Sexual Orientation