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Principal Sustaining Engineer
hace 2 semanas
**About Teleflex Incorporated**
**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**:
**Principal Responsibilities**:
- Provide engineering support to design and/or process alterations to existing products
- Manage engineering activity required to support products through the commercialized life cycle
- Coordinate Design Change and Process Change activities
- Assess proposed Design and Process Changes for the impact to the organization; create evidence based project proposals
- Develop design inputs and design outputs for changes to existing product
- Develop new test methods and/or alter existing test methods
- 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.
- Lead commercialized product change project teams and maintain design history files
- Ensure design change and process change activities, processes and practices are in compliance with internal quality system requirements.
- Maintain and supplement design history files that are thorough and accurate for existing product
- Interview, select, train and evaluate performance of new hires
- Mentor and train Sustaining Engineers
- Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
**Education / Experience Requirements**:
- Bachelor’s degree in a relevant field.
- Eight years of relevant experience required.
**Specialized Skills / Other Requirements**:
- Must bilingual (English/Spanish)
- Must possess knowledge, understanding and skills in: product designs/concepts, catheter materials, project management, documentation, and a working knowledge of quality systems and medical device regulations.
- Excellent collaborator and communicator of technical concepts to a large audience.
- Ability to work cross functionally and across muliple levels within the organization to support initiatives, obtain stakeholder feedback, and drive critical decisions of projects.
- 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 required.
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