Validation Engineer

Validation Engineer

Kelly Engineering is seeking a Validation Engineer for a long-term contract with one of our Global Medical Device clients located in Irvine, CA.

Our Client is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide As a Kelly employee, you will be eligible for Medical & Dental 50% paid, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

All KellyOCG employees receive annual performance reviews.

Essential Duties And Responsibilities Include The Following:

• Aid in defining how the device's specifications shall be tested.
• Interface with product development teams to support the development and implementation the most appropriate test methods for conducting design verification testing.
• Design, develop, document, and implement test equipment and test specifications as required.
• Work with external test equipment suppliers and/or testing facilities as needed.
• Perform measurements, analysis data, create engineering designs, develop test plans, and maintain laboratory notebooks on all work.
• Generate protocols and reports
• Must comply with all design-related standards as developed by regulatory groups such as ISO, FDA, etc.
• Must comply with department and corporate quality and safety initiatives.

Qualification Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• A Bachelor's Degree in Mechanical Engineering
• 5-7 years of engineering experience in medical devices and/or material/product testing; or equivalent combination of education and experience.
• Knowledge and experience in the development of processes and their formal documentation.
• Knowledge of relevant international standards; knowledge of GDP and other relevant regulatory requirements; knowledge of GD T and basic drawing standards; knowledge and experience with Solid Works

Other

Skills And Abilities:

Strong analytical reasoning with excellent communication skills. Knowledge, skill, and ability to provide technical support to project teams. Safety Requirements:
Adhere to company safety rules and practices. Be proactive in ensuring safety in work area. Immediately report incidents or unsafe conditions. Know emergency procedures.

Important information:
This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship.