Test Engineer - Medical Devices

Job Title : Test Method Engineer

Location : Maple Grove, MN

Job Type : Long-Term

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.
• 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.

Qualifications

Additional Skills & Qualifications

Seniority level

Employment type

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