Validation Engineer

Raynham, MA, US • Posted 30+ days ago • Updated 2 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Medical Devices
Regulatory Compliance
Functional Testing
Documentation
GDP
ISO 13485
Mechanical Engineering
Testing
Data Acquisition

Summary

Summary:

Supports testing and validation activities for medical devices, ensuring compliance with regulatory and quality standards.
bility to interpret engineering drawings and specifications.

Roles & Responsibilities:

Develop Test Protocols aligned with design verification plans and regulatory requirements.
Prepare test samples and fixtures for mechanical and functional testing.
Execute tests and document results per Good Documentation Practices (GDP). Generate Test Reports for inclusion in the Design History File (DHF).
Coordinate with cross-functional teams to ensure timely completion of testing activities.

Experience Required:

2 - 4 years experience.
Familiarity with ISO 13485 and FDA QSR requirements preferred.
Hands-on experience with mechanical testing and data acquisition systems.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: f0aef7e32369d6d26433b7e0ccbbe1df
Posted 30+ days ago

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