Job Description
The Test Method Engineer will be responsible for reviewing and assessing legacy test methods, identifying gaps, inconsistencies, and improvement opportunities in existing methods. The role involves remediating test methods to meet current standards and best practices, evaluating and documenting the risk of changes to test methods, and ensuring traceability and justification. Collaboration with cross-functional teams such as R&D, Quality, and Regulatory Affairs is essential.
Responsibilities
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.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.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.Additional Skills & Qualifications
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.Pay and Benefits
The pay range for this position is $55.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
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)
Workplace Type
This is a fully onsite position in Minneapolis,MN.
Application Deadline
This position is anticipated to close on Sep 10, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.