Job description
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
Brief statement summarizing the primary objective or purpose of the position.
As part of the Interventional Business Unit’s Research & Development Team, the Sustaining Engineer II role provides engineering support to design and/or process alterations to existing products. Responsibilities will include scoping planning, and executing design-related deliverables and projects within the Teleflex Design Control process.
Principal Responsibilities
- Coordinate Design Change and Process Change activities.
- Develop design inputs and design outputs for changes to existing product or new distributed product.
- Provide R&D support for verification, qualification, and validation studies on existing products.
- Support risk management activities and risk management reviews on existing products.
- Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.
- Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
- Support regulatory approvals and responses to regulatory questions for existing products.
Education / Experience Requirements
- Bachelor’s degree. Relevant experience may be considered in lieu of degree.
- 2+ years related experience working in a new product development, sustaining engineering, quality engineering or design assurance role
- Medical device experience a plus.
Specialized Skills / Other Requirements
- Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design is preferred
- Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.
- Self-motivated individual with proven ability to work independently from objectives
- Proven problem solving and trouble shooting skills
- Experience with quality management systems and medical device regulations
- Proven communication skills with cross-functional interaction
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.
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