Want to hear how I work? Hit play.Find roles with Kablio AI to help build and power the world.Kablio AI helps you secure roles in construction, clean energy, facilities management, engineering, architecture, sustainability, environment and other physical world sectors.
Get hired, get rewarded!
Land a job through Kablio and earn a 5% salary bonus.
Exclusive benefits
5%Bonus
Test Method Engineer (Mechanical)
Actalent
An engineering and sciences services and talent solutions firm connecting specialized experts with industry projects.
Review and remediate legacy medical device test methods, develop new protocols.
Ensure all updates align with applicable regulatory and industry standards.
Remediate test methods to meet current standards and best practices.
Evaluate and document the risk of changes to test methods, ensuring traceability and justification.
Provide technical documentation and support for internal audits and reviews.
Identify gaps, inconsistencies, and opportunities for improvement in existing methods.
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.
Collaborate with cross-functional teams including R&D, Quality, and Regulatory Affairs.
What you bring
bachelor's
regulatory
iso
21 cfr
fmea
lab equipment
Knowledge of regulatory requirements (FDA, EU MDR).
Bachelor’s degree in Engineering or related field.
Strong understanding of test method development and remediation.
Experience with ISO and ASTM standards relevant to medical devices.
Experience with tubes, bonds, sterility, catheters, and fluid-based testing is highly desirable.
Hands-on experience with lab equipment and test setups.
Experience with 21 CFR 820.30.
Minimum 4 years of experience in the medical device industry.
Excellent analytical, documentation, and communication skills.
Ability to work independently and onsite.
Experience with Class III Single Use Devices.
Familiarity with risk assessment methodologies (e.g., FMEA).
Experience with ISO standards is highly desirable.
Benefits
Time Off/Leave (PTO, Vacation or Sick Leave)
Health Spending Account (HSA)
Employee Assistance Program
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Transportation benefits
Medical, dental & vision
Critical Illness, Accident, and Hospital
Short and long-term disability
401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
Hey there! Before you dive into all the good stuff on our site, let’s talk cookies—the digital kind. We use these little helpers to give you the best experience we can, remember your preferences, and even suggest things you might love. But don’t worry, we only use them with your permission and handle them with care.