Sustaining Engineer EU MDR

Date: Feb 22, 2021

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3473

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. 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 Mansfield, MA based Sustaining Engineer is responsible for the execution of product performance testing and design control deliverables associated with design file remediation and sustaining projects to meet European Union Medical Device Regulation (MDR) requirements.  This position interfaces with crossfunctional teams to complete sustaining projects, design control deliverables, and activities to ensure Teleflex Medical OEM suture products meet evolving standards in the European Union (EU).  Products will include EU Class IIb and III devices.  Scope of projects will also include sustaining and remediation activities to ensure proper data is on file to support EU MDR information required by contract manufactured, sterile and non-sterile component customers.

Principal Responsibilities

•    Plan and execute activities to update and sustain Tech Files and Design Dossiers in preparation for new MDR regulations. 
•    Management and coordination of multiple EU MDR deliverables to ensure tasks are completed to meet target dates as defined by the EU MDR Progam Manager and BU Regulatory lead.
•    Provide progress updates on the assigned MDR compliance projects to OEM cross functional teams and leadership.
•    Planning and execution of deliverables/projects to identify and remove hazardous substances as defined by EU/MDR 2017/745.
•    Interface with Suppliers, Customers,Purchasing, Quality, Marketing and Regulatory Affairs to deliver projects.
•    Coordinate with and support Purchasing in supplier related MDR compliance activities.
•    Plan and lead the verification and validation activities for EU MDR remediation, and/or new/replacement materials as per product requirements.
•    Work in conjunction with Regulatory lead to obtain additional MDR training, as needed. 
•    Ensure consistency in approach of assigned MDR remediation and sustaining projects/deliverables.
•    Execution of project risk planning and response activities.
•    Coordinate and implement laboratory testing, data analysis and preparation of technical reports as required by the project teams.
•    Execute development/improvement of products and processes, optimize by utilizing tools such as DOE, accomplish their evaluation through verification and validation.
•    Interface with suppliers to obtain information required to update Tech Files and DHF documentation.
•    Interface with purchasing and Sales Ops to support development of customer and supplier agreements as they relate to EU MDR requirements.
•    Support Product Development activities such as Change Order management, protocol generation, test execution,  as needed.
•    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’s Degree required. Engineering or technical discipline preferred.
•    Minimum 2-3 years of previous experience in related field (e.g. medical device or component manufacturing, product development and manufacturing processes, regulated industry)
•    Minimum 1-3 years of previous experience successfully leading projects and project deliverables.
•    U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred
•    Knowledge of and experience with EU MDR regulations and/or compliance projects is highly preferred
•    PMP certification is preferred
 

Specialized Skills / Other Requirements

•    Focus on detailed work with emphasis on accuracy and completeness
•    Effective written and oral communication skills
•    Excellent organizational and planning skills; drives for results
•    Effective analytical/problem solving skills
•    Strong interpersonal skills that include working well in a team environment with the ability to effectively 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 regulations, requirements and/or ISO 13485 quality systems
•    Proficient in Microsoft Office – PC, Word, Excel, PowerPoint, Project (or equivalent)
 

 

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: New Bedford