R&D Engineer- MDR

Date: Feb 8, 2021

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3387

 

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.

 

Respiratory - Patients and caregivers around the world rely on Teleflex and the Hudson RCI® brand of respiratory products to make breathing easier. Guided by the voice of the clinician, Teleflex strives to advance patient care by focusing on improving patient outcomes while delivering caregiver efficiency. By incorporating the needs of the caregiver into every product we develop, our goal is to advance patient safety and, ultimately, achieve the best patient outcome possible. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This Morrisville, NC based R&D Project Engineer is responsible for the planning and execution of product performance testing and to meet European Union Medical Device Regulation (MDR) requirements.  This position participates and interfaces with teams on a global scale to ensure that our products are compliant to new and emerging medical device directives. In particular, this role will be charged with ensuring that our products meet evolving standard in the European Union (EU).  Products will include Class IIa and IIb respiratory devices.  The medical device products sold in the business unit include humidifiers and nebulizers, heated humidification systems, and incentive spirometry devices

The candidate will lead and participate in cross-functional reviews of the medical device files to ensure all test requirements are being planned and executed in a timely manner.  This ensures compliance that enables the business to meet all requirements to manufacture and sell medical devices in the EU.

Principal Responsibilities

•    Primary responsibility is to assist, plan and coordinate activities of technical resources assigned to updating design documentation in preparation for new MDR regulations. 
•    Participate in the overall planning activities to meet target dates as defined by the BU regulatory lead.
•    Generate test protocols, analyze test data, and generate written reports.
•    Contribute to design documentation including input for the design history files (DHF) and technical design reviews.
•    For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.
•    Meet project objectives, milestones, and target dates. Support MDR project management with the technical update and review of the project progress on an as-required basis by supervisor.
•    Interface with suppliers to obtain information required to update Tech Files and DHF documentation. Interface with purchasing and marketing to develop supplier agreements for components and/or new products.
•    Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
•    Lead and participate in design and technical phase reviews.
•    Ensure projects are developed and documented compliant with the Quality System.
•    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

Education / Experience Requirements

•    Bachelor of Science – Biomedical Engineering or equivalent technical discipline
•    2-3 years of previous experience in development engineering, sustaining engineering or project management in medical device preferred or related fields (e.g. FDA regulated industry)
•    PMP certification or relevant experience managing complex projects with a multi-functional team 

Specialized Skills / Other Requirements

•    Working knowledge of U.S. FDA Medical Device GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred
•    Orientation for detailed work with emphasis on accuracy and completeness
•    Effective written and oral communication skills
•    Good organizational and planning skills; drives for results
•    Effective analytical/problem solving skills
•    Good interpersonal skills that include working well in a team environment and the ability to lead others
•    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices
•    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision
•    Working knowledge of international requirements and quality systems
•    Intermediate knowledge of Microsoft Office suite - Word, Excel, PowerPoint

 

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