Job Description

Job Title: Validation Engineer (Medical Devices)
Duration : 12+ Months ( W2)

Job Description:
We are seeking a highly skilled and detail-oriented Validation Engineer position in the medical device industry. The ideal candidate will have experience in validating medical devices and ensuring compliance with regulatory standards such as FDA and ISO 13485. As a key member of the team, you will be responsible for executing and documenting validation protocols, supporting product development, and ensuring quality assurance throughout the lifecycle of medical devices.

Key Responsibilities:
Develop, execute, and document validation protocols for medical device products in compliance with FDA, ISO 13485, and other regulatory requirements.
Coordinate and perform validation testing (IQ, OQ, PQ) for equipment, systems, and processes.
Prepare and review validation reports to ensure they meet regulatory and quality standards.
Collaborate with cross-functional teams, including R&D, quality assurance, manufacturing, and regulatory affairs, to support product development and validation efforts.
Perform risk assessments and create risk management documentation in compliance with medical device standards.
Provide technical support to ensure the timely resolution of validation-related issues during product lifecycle.
Ensure compliance with Good Manufacturing Practices (GMP) and other industry-specific quality standards.
Assist in the creation and maintenance of SOPs related to validation processes.
Maintain up-to-date knowledge of current industry practices, regulations, and standards to ensure best practices in validation processes.

Qualifications :
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
3-5 years of experience in validation engineering within the medical device industry.
In-depth knowledge of FDA regulations, ISO 13485, and other applicable quality standards (e.g., 21 CFR Part 820).
Experience with validation of medical devices and manufacturing processes, including IQ, OQ, and PQ protocols.
Strong understanding of risk management principles and experience with risk assessments (e.g., FMEA, DFMEA).
Familiarity with documentation control and ability to write clear, concise validation reports.
Proficiency with validation tools and software.
Strong attention to detail, problem-solving skills, and ability to work under minimal supervision.
Excellent communication and interpersonal skills.

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