Job Description

Job Description

We are seeking a skilled and detail-oriented Test Method Engineer with experience in the medical device industry to support the review and remediation of legacy test methods. This role is crucial in ensuring the adequacy and compliance of existing test protocols for devices such as tubes, bonds, sterility, and catheters, with a focus on fluid-based testing. The engineer will also be responsible for creating new test protocols utilizing product risk documentation.

Responsibilities

• Review and assess legacy test methods, including leak pressure, Luer leak testing, label adhesion, Luer standard compliance, microsphere mass, tensile tubing bonds, and needle engagement.
• Identify gaps, inconsistencies, and opportunities for improvement in existing methods.
• Remediate test methods to meet current standards and best practices.
• Evaluate and document the risk of changes to test methods, ensuring traceability and justification.
• Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs.
• Ensure all updates align with applicable regulatory and industry standards.
• Provide technical documentation and support for internal audits and reviews.

Essential Skills

• Bachelor’s degree in Engineering or related field.
• Minimum 4 years of experience in the medical device industry.
• Strong understanding of test method development and remediation.
• Familiarity with risk assessment methodologies (e.g., FMEA).
• Excellent analytical, documentation, and communication skills.
• Ability to work independently and onsite.
• Experience with Class III Single Use Devices.
• Experience with 21 CFR 820.30.

Additional Skills & Qualifications

• Experience with ISO standards is highly desirable.
• Experience with tubes, bonds, sterility, catheters, and fluid-based testing is highly desirable.
• Experience with ISO and ASTM standards relevant to medical devices.
• Knowledge of regulatory requirements (FDA, EU MDR).
• Hands-on experience with lab equipment and test setups

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