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About Teleflex Incorporated

Medical Device Innovation

Teleflex Incorporated is a leading global provider of medical devices that diagnose and treat coronary and peripheral vascular diseases. Our Interventional business unit offers innovative solutions that are used by healthcare providers to make a difference in patients' lives.

Position Summary

Key Responsibilities

• Provide engineering support to design and/or process alterations to existing medical devices
• Manage engineering activity required to support products through their 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 medical devices
• Develop new test methods and/or alter existing test methods
• Provide R&D support for verification, qualification, and validation studies on existing medical devices
• Support risk management activities and risk management reviews on existing medical devices
• 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 CAPAs, and report generation
• Support regulatory approvals and responses to regulatory questions for existing medical devices
• 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 medical devices
• 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.

Six years of relevant experience required.

Specialized Skills / Other Requirements

Must possess knowledge, understanding, and skills in:

• Product designs/concepts
• Catheter materials
• Project management
• Documentation
• Quality systems and medical device regulations

Excellent collaborator and communicator of technical concepts to a large audience.

Ability to work cross-functionally and across multiple 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.