
Test Method Engineer
- Maple Grove, MN
- $55.00-60.00 per hour
- Contract
- Full-time
- Review and assess legacy test methods including burst pressure, luer leak testing, label adhesion, luer standard compliance, and microshear mass.
- Identify gaps, inconsistencies, and opportunities for improvement in existing test methods.
- Remediate test methods to align with 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.
- Develop and refine test fixtures using SolidWorks to support updated methods.
- Ensure all updates comply 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.
- Proficiency in SolidWorks for fixture design and development.
- Familiarity with risk assessment methodologies (e.g., FMEA).
- Excellent analytical, documentation, and communication skills.
- Ability to work independently and onsite.
- Experience with balloons, catheters, and fluid-based testing.
- Experience with ASTM standards relevant to medical devices.
- Knowledge of regulatory requirements (FDA, EU MDR).
- Hands-on experience with lab equipment and test setups.
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)