Test Services Engineer II, MDR at Teleflex in Maple Grove, Minnesota

Posted in Other 10 days ago.

Job Description:

Expected Travel: Up to 10%

Requisition ID: 6159

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

Position Summary

• Develop and support creation of accurate, effective, qualified and validated test methods that can be used efficiently by Test Services personnel
• Technical training of Test Services personnel.
• Provide technical support for product development and manufacturing departments in regards to test method validity and appropriateness.
• Source and coordinate outside test services.

Principal Responsibilities

• Perform product tests (DVT, accelerated aging, real time aging and OQ/PQ) per test procedures and protocols
• Coordinate tests to meet the required deadlines for all projects and communicate status to management.
• Coordinate tests with external services
• Work with suppliers to create or improve new testing capabilities
• Collaborate with R&D, Product Quality and Process Development on test procedure development, improvements and validity
• Perform timely and accurate equipment and test procedure qualifications/validations and associated Gage R&R activities
• Maintain calibration and qualification programs within the laboratory
• Enforce and maintain GLP/GMP documentation practices
• Train and mentor Test Services Technicians on test procedures and development of documentation and training skills
• Develop and validate test methods, procedures and equipment for specific applications within the Test Services Department
• Manage and coordinate calibration activities within the assigned area, including NCE investigations and analysis.

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required
• 2 years of applicable Engineering experience

Specialized Skills / Other Requirements

• Project management acumen and ability to coordinate detailed documentation creation and release per scheduled requirement
• Effective verbal and written communication skills
• Proficient in technical report writing and review
• Strong interpersonal and training skills; working in a team as a contributor and as an individual contributor
• Structured approach to problem solving
• Understands validation principles and Gage R&R

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2021 Teleflex Incorporated. All rights reserved.

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