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Validation Engineer Medical Devices Jobs in Rochester, NY

Bausch + Lomb

Medical Device Engineer I

Rochester, NY · On-site

$65K - $100K/yr

Track record of contributing to product launches or design verification/validation activities ... Understanding of design controls for medical devices * Experience with Design for Six Sigma (DFSS ...

Integrated Resources INC

Scientist I

Rochester, NY

... and Validation) for Medical Devices. Experience or knowledge of evaluation and statistical analysis using methods such as the CLSI documents. Experience in identifying and resolving problems for ...

iSpace, Inc

Software Engineer C++

Rochester, NY · On-site

Title: Sr Software Engineer (C++) Location: Rochester, NY Duration: Full-Time Employment Hybrid ... Preferred: * 5 years of experience with software development for medical devices or another ...

Varsity Tutors

Biomedical Engineering Tutor

Rochester, NY · Remote

$18 - $40/hr

Adapts instruction using case studies of medical devices, MATLAB simulation exercises, and design project guidance to support undergraduate biomedical engineering students bridging life sciences and ...

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Validation Engineer Medical Devices information

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

As of Jul 17, 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 job?

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 in the Validation Engineer Medical Devices position, and why are they important?

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
Validation Engineer (Medical Device)

Validation Engineer (Medical Device)

Caresoft

Rochester, NY • On-site

Other

Posted 5 days ago

Job description

Title: Valdiation Engineer (Medical Device)
Location: Rochester NY
Duration: 12 Months

Overview:
This role supports validation activities for new products within a medical device manufacturing facility and requires the ability to work both independently and as part of a cross-functional team.
Key Responsibilities
Support validation work for new products, including laboratory testing utilizing VITROS analyzers.
Prepare and handle clinical test specimens according to approved procedures, best practices, and safety requirements, including appropriate PPE.
Perform pilot-scale formulations with biological materials, as needed.
Operate and maintain laboratory equipment; complete all required documentation in real time (QC records, instrument logs, test records).
Independently execute laboratory experiments and assist with troubleshooting instrument and test failures, as needed.
Review and analyze data; document conclusions and test summaries in appropriate quality records within QuidelOrtho's quality system.
Ensure organization, documentation, and tracking of long-term studies with multiple factors, products, and conditions.
Maintain a working knowledge of cGMP requirements and adhere to all quality, regulatory, and safety guidelines.
This role involves both laboratory and computer-based work.
Skills Required:
Bachelor's degree in a scientific field (e.g., Chemistry, Biology, or equivalent) required.
Experience in an FDA-regulated industry and in validation for medical devices preferred.
Familiarity with VITROS products and VITROS analyzers highly desired.
Familiarity with biological formulations and processing techniques highly desired.
Strong written and verbal communication skills with excellent attention to detail required.
Strong organizational skills and ability to manage complex, long-term studies required.
Proficiency in Excel required, with additional statistical analysis skills preferred.

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