ZipRecruiter

Log In

1

Validation Engineer Medical Devices Jobs in Ohio

adareps

Validation Engineer

Vandalia, OH

Our benefits package is highly competitive, offering medical, dental, and vision coverage; a ... Position Validation Engineer Location Vandalia, Ohio Summary In this position, the Engineer will ...

Adare Pharma

Validation Engineer

Vandalia, OH · On-site

Our benefits package is highly competitive, offering medical, dental, and vision coverage; a ... Position Validation Engineer Location Vandalia, Ohio Summary In this position, the Engineer will ...

previous pagenext page

Showing results 21-40

All JobsValidation Engineer Medical Devices JobsValidation Engineer Medical Devices Jobs in Ohio

Validation Engineer Medical Devices information

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 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 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 popular job titles related to Validation Engineer Medical Devices jobs in Ohio?

For Validation Engineer Medical Devices jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Medical Devices jobs in Ohio look for?

The top searched job categories for Validation Engineer Medical Devices jobs in Ohio are:

Validation Engineer Medical Devices jobs near you
Infographic showing various Validation Engineer Medical Devices job openings in Ohio as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 12% Part Time, and 6% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution.

Mechanical Product validation Engineer

Ruri Software Technologies LLC

Cincinnati, OH • On-site

Full-time

Posted 10 days ago

Job description

Job Title :Mechanical Product validation Engineer
Location: Onsite. Cincinnati, OH
Job Description:
Job summary :
Mechanical Product Validation Engineer with hands on expertise in cleaning, sterilization and reprocessing validation for reusable medical devices. Experienced in developing test methods, executing C&S feasibility and validation studies, conducting GR&R and root cause analysis and supporting risk management and design reviews through cross functional collaboration.
Responsibilities :
• Develop soiling, cleaning and extraction processes for reusable scopes and instruments and accessories (I&A), incorporating real world use conditions and cleanability considerations.
• Plan, execute and analyze Cleaning and Sterilization (C&S) feasibility studies, cleanability assessments and sterilization validations for reusable scopes and I&A.
• Create and qualify test methods, perform Gage Repeatability & Reproducibility (GR&R) studies and document results in engineering studies, test protocols, reports and validation documentation, including statistical analysis as required.
• Conduct root cause analysis for C&S process issues and evaluation findings and communicate data driven solutions and recommendations to R&D and cross functional stakeholders.
• Support development and completion of associated risk management documentation (e.g., DFMEA, PFMEA, hazard analyses) by providing hands on laboratory expertise and technical input.
• Support Design Reviews and Phase Exit Reviews by preparing required documentation, developing presentation materials and presenting technical content related to cleaning, sterilization and reprocessing.
• Partner with internal teams and external supplier resources (e.g., test laboratories, sterilization vendors) to ensure timely completion of product development and launch deliverables.
Top Skills:
Cleaning & Sterilization Validation, Test Method Development, product quality, DFMEA
Additional Information:
B.E Mechanical Engineer or equivalent
Experience : 5 to 10Yrs
Years of Experience: 10.00 Years of Experience
Regards
Surya
surya@rurisoft.com

Apply