ZipRecruiter

Log In

1

Validation Engineer Medical Devices Jobs in Rochester, NY

SAPSOL Technologies Inc

Medical Engineer

Rochester, NY · On-site

This role supports the development, integration, and validation of advanced MRI methods across two ... Master's or PhD in MRI Physics, Biomedical Engineering, Medical Physics, Electrical Engineering ...

Sapsol Technologies Inc

Medical Engineer

Rochester, NY · On-site

This role supports the development, integration, and validation of advanced MRI methods across two ... Master's or PhD in MRI Physics, Biomedical Engineering, Medical Physics, Electrical Engineering ...

next page

Showing results 1-20

All JobsValidation Engineer Medical Devices JobsValidation Engineer Medical Devices Jobs in Rochester, NY

Validation Engineer Medical Devices information

See Rochester, NY salary details

$22

$51

$77

How much do validation engineer medical devices jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for validation engineer medical devices in Rochester, NY is $51.30, according to ZipRecruiter salary data. Most workers in this role earn between $38.89 and $62.36 per hour, depending on experience, location, and employer.

What is a validation engineer medical devices?

A Validation Engineer in medical devices ensures that products, processes, and equipment meet regulatory and quality standards. They develop and execute validation protocols, conduct tests, analyze data, and document results to ensure compliance with FDA, ISO 13485, and other regulations. Their role is crucial in verifying that medical devices are safe, effective, and consistent in performance before they reach the market.

What are some typical challenges faced by validation engineers in the medical device industry?

Validation Engineers in the medical device industry often encounter challenges such as navigating ever-evolving regulatory standards, managing tight project timelines, and ensuring thorough documentation for audits. They are frequently tasked with balancing the need for comprehensive testing and validation with efficiency to support product development cycles. Working closely with cross-functional teams—including design, quality assurance, and manufacturing—requires strong collaboration and adaptability. Overcoming these challenges helps ensure that medical devices are safe, effective, and compliant with industry regulations, making the role both demanding and highly impactful.

What are the key skills and qualifications needed to thrive as a validation engineer medical devices?

A Validation Engineer in Medical Devices needs a strong background in biomedical engineering or a related field, knowledge of regulatory requirements (such as FDA or ISO 13485), and expertise in validation methodologies. Familiarity with tools like statistical analysis software, quality management systems (QMS), and documentation platforms is often required, as well as certifications such as CQE (Certified Quality Engineer). Strong attention to detail, problem-solving abilities, and effective communication skills are essential to excel in this role. These competencies are critical to ensure medical devices meet rigorous safety and compliance standards, protecting patient health and supporting successful product launches.

What are popular job titles related to Validation Engineer Medical Devices jobs in Rochester, NY? For Validation Engineer Medical Devices jobs in Rochester, NY, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Medical Devices jobs in Rochester, NY look for? The top searched job categories for Validation Engineer Medical Devices jobs in Rochester, NY are:
Validation Engineer Medical Devices jobs near you
Infographic showing various Validation Engineer Medical Devices job openings in Rochester, NY as of July 2026, with employment types broken down into 1% As Needed, 79% Full Time, 15% Part Time, 1% Temporary, 3% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $106,711 per year, or $51.3 per hour.

Instrument Verification and Validation Engineer (Medical Device)

Caresoft Inc.

Rochester, NY • On-site

$45 - $50/hr

Contractor

Re-posted 14 days ago

Job description

Job Summary for Sr. Instrument Verification and Validation Engineer
- Lead formal verification and validation (V&V) activities for complex medical devices in compliance with FDA regulations.
- Design and implement software for embedded devices and systems, including developing, coding, testing, and debugging system software.
- Develop and execute requirements-based manual test cases and procedures in a BL2 lab environment.
- Analyze test results, document findings, and manage system software defects.
- Assess system requirements for testability and determine optimal test approaches.
- Participate in collaborative team meetings, formal reviews, and test planning activities.
- Work closely with software development teams and partners to reproduce and verify system defects.
- Support project goals and timelines to ensure successful product launch.
- Engage in off-hour meetings with international partners (e.g., China).
- Ensure compliance with relevant standards (IEC 62304, ISO 13485, ISO 14971, FDA QSR).
- Apply experience in product development, experimental design, and quality systems regulations.
- Utilize configuration management, defect tracking, and peer review tools.
- Prepare test plans, test cases, and test reports.
- Manage multiple tasks and work within cross-functional teams.
- Maintain professionalism, strong communication skills, and a proactive, self-motivated work ethic.
- 100% onsite work at Rochester, NY location with up to 20% travel (airplane, car, overnight stays).
- Willingness to work overtime and attend early/late meetings as required.