Design Assurance Technician II, MDR
Teleflex

Job Info

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Expected Travel: Up to 10%

Requisition ID:3691

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

• Improve and qualify new test methods for evaluation of new product designs during verification/validation studies, including development/qualification of test equipment and execution of test method validations
• Manage execution of design verification/validation studies to demonstrate effectiveness of new product designs and design changes
• Execute other design assurance deliverables to support new product development and design changes

Principal Responsibilities

• Prepare test methods for success in test method validation and for anticipated test lab use
o Assist in drafting new test methods
o Maintain and improve test methods in preparation for test method validation and upcoming studies
o Plan, perform, and coordinate test method validations
o Develop, improve, and qualify test lab equipment
• Manage execution of design verification/validation studies and other studies conducted by the Design Assurance group.
o Coordinate delivery/conditioning of test samples
o Support test lab training and efficiency
o Track test completion
o Effectively communicate study status to product development team
o Lead investigation/documentation of study issues and deviations
o Review/analyze data
o Assist in drafting protocols/reports
• Execute other design assurance activities for new product development and sustaining projects as needed, including:
o Product specifications
o Risk management
o Component qualification
o Inspection procedures and first article inspections
o Material evaluation
o Lot release testing
o Standards reports

Education / Experience Requirements

• Associate degree in a scientific discipline or two years of related experience required. BA/BS in physical/life science or engineering preferred.
• Four years of additional experience required in combination with associate degree/two years of related experience. Two years of related experience required in combination with a BA/BS degree.

Specialized Skills / Other Requirements

• Strong organizational skills, able to independently organize/prioritize individual work and project work
• Attention to detail, especially in review/completion of written work
• Critical thinking/problem solving skills
• Effective verbal and written communication skills
• Interpersonal skills, ability to work and communicate with cross-functional teams as well explain/train others on test procedures and protocols
• Proficient in Microsoft office tools (Word, Excel, etc)
• Proficient in technical writing and review, including thorough written rationales to justify decisions/strategies
• Familiarity with statistical analysis software such as Minitab
• Familiarity with industry standards and requirements (ISO 13485, FDA 21 CFR 820, technical standards)

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.

© 2021Teleflex Incorporated. All rights reserved.

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