Project Engineer

Date: May 11, 2022

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 6232

 

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.

 

Surgical - Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our MiniLap® Percutaneous Surgical System to Weck® Hem-o-lok® Polymer Locking Ligation System, and Weck EFx® Shield™ Fascial Closure System, our portfolio of products adds up to a powerful offering of solutions that helps improve patient outcomes. These innovative, minimally invasive surgery products are offered alongside time-tested and trusted Pilling® Surgical Instrument and Lightsource solutions to provide a comprehensive set of solutions to meet the challenges of an evolving healthcare environment. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Project Engineering position will be responsible for all aspects of product sustainability for the Ligation portfolio from design control related design changes to investigations and root cause analysis, and working with the supplier on any design related changes or improvements.   This engineer will serve in a technical role with key responsibilities of project management inclusive of collaboration and leadership with key internal and external stakeholders.   A successful candidate will understand and be knowledgeable 
in key aspects of project management, design control, supply chain, manufacturing and inspection requirements as these relate to Product Sustainability.


We are looking for someone who is:  

•    A motivated self-starter with effective interpersonal and leadership skills
•    An organized and detailed orientated individual who is adept at problem solving 
•    Committed to collaboration and teamwork with internal and external stakeholders 
•    Able to balance competing interests and lead to resolution with mutual commitment 
 

Principal Responsibilities

•    As an integral part of the project team and or leader of a project team, provides design, manufacturing, supply, component, timing and assembly expertise to projects
•    Work closely with SME’s to define sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples etc. 
•    Managing project related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team
•    Responsible for managing / communicating validation schedules including IQ/OQ/PQ, product production within agreed upon scope, budget, timeline and quality with external partners 
•    Interface with suppliers and manufacturing when implementing new processes
•    Ensure all supporting documentation is drafted, approved and documented with SAP and Agile . 
•    Support and lead efforts to generate, review and approve design control documentation.   
•    Develop test plans, protocols, and reports. Analyze and present results, applying engineering analysis as necessary
•    Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems
•    
•    Drives quality improvements by risk assessment/mitigation eliminating sources of defects in the design, new product introduction and manufacturing processes. 
•    Remain current with all internal and appropriate external developments and policies in related areas of activity
•    Establish SOP(s) where appropriate and initiate training, adherence to:
•    TMV(s) (Test Method Validation)
•    Real Time Aging retention, testing
•    V&V testing, including IQ/OQ/PQ and PPQ Documentation, lab notebooks
•    Support Engineering Evaluation of returned product when required.
•    Support Design and Development plans and Change Orders, technical reviews and implementation 
•    Provide other department support as requested by immediate supervisor
 

Education / Experience Requirements

•    Prefer Bachelor level degree in Engineering / Technology or equivalent experience in medical device operation, planning and new product introduction
•    At least 3 years minimum engineering experience within a medical device environment
•    Experience working with manufacturing suppliers preferred
•    Excellent communication, presentation and multi-functional departmental leadership
•    A comprehensive understanding of ISO, GMP and FDA regulations
•    Experience in the commercialization of medical devices in U.S., globally is preferred.
 

Specialized Skills / Other Requirements

•    Strong analytical and problem-solving skills and comprehensive understanding of design control processes and validation of processes and designs.
•    Effective verbal, presentation, and written communication skills.
•    Excellent interpersonal skills with demonstrated leadership, organizational influence and decision-making competencies.
•    Proficient in Microsoft Office, and MS project.
•    Adept at CAD, ideally Solidworks
•    Working knowledge of medical device development, sterilization requirements and techniques, medical device regulations, and implantable medical device design requirements
•    Large company experience working with mulitple departments and locations
•    Willingness to travel out of the country as required
 

 

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.


Nearest Major Market: Raleigh