Validation Engineer

Katalyst HealthCares and Life Sciences

• $70K — $95K *
Raynham, MA 02767In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • 2 - 4 years of relevant experience in testing and validation of medical devices.
  • Familiarity with ISO 13485 and FDA QSR regulatory requirements is preferred.
  • Hands-on experience with mechanical testing and data acquisition systems.
  • Ability to interpret engineering drawings and specifications.
  • Strong understanding of Good Documentation Practices (GDP).

Responsibilities

  • Develop test protocols that meet design verification plans and regulatory standards.
  • Prepare test samples and fixtures for both mechanical and functional testing.
  • Execute tests and document results according to Good Documentation Practices.
  • Generate comprehensive test reports for the Design History File (DHF).
  • Coordinate with cross-functional teams to ensure timely testing completion.
Full Job Description
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.
* Ladders Estimates

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