R&D Engineer, Sustaining

Date: May 9, 2022

Location: Morrisville, NC, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 6242

 

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.

 

Anesthesia and Emergency Medicine - At Teleflex, we promote the use of advanced anesthesia and emergency medicine techniques to help improve outcomes and reduce healthcare costs. We equip clinicians with some of the most advanced medical devices on the market today, from our world-class brands including: 

  • LMA® and Rüsch® airway management devices designed to help reduce the risk of airway-related complications. 
  • Arrow pain management products designed to improve patients' post-operative pain experience. 
  • The Arrow® EZ-IO® System that helps address the time-critical challenge of emergency vascular access, and 
  • QuikClot® and QuickClot Control+® hemostatic devices, used by hospitals, EMS, and the military for hemorrhage control in a broad range of bleeding situations. 

Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives. 

Position Summary

Under general direction, the Sustaining R&D Engineer, based in Morrisville NC, is responsible for the sustaining engineering projects of Anesthesia and Emergency medicine products.  Experience and background requirements should focus on disposable medical device products. This position has PTG (Product Technology Group) responsibility, including organizing and managing multiple projects and ensuring they are completed in a timely manner.  Assignments will primarily be focused on existing products within the portfolio, providing creative solutions to technical issues or modifying/improving the product as required.

The candidate must be capable of advanced level scope of assignments in planning, designing, and coordinating the development and implementation of related engineering activities to support changes and improvements to existing products lines, and implement successfully into manufacturing. Incumbent at this level self-manages their project work, seeks help when required, and is fully aware of the operating procedures and policies of the work unit.

Principal Responsibilities

•    Acts as product technology group owner/subject matter expert for assigned product lines.
•    Coordinates the product design and development process with appropriate support departments such as engineering, quality, regulatory, marketing, documentation, operations, procurement.
•    Serve as an R&D technical lead representative in transfer, integration, or other corporate initiative core teams. Collaborate with Engineering, Quality, and Regulatory to understand technical targets and design control systems. 
•    Serves as project leader for assigned projects; responsible to follow up on all aspects of projects. Reports project statuses and key metrics and dashboard updates to required systems.
•    Resolves complex process/product development and manufacturing issues; independently takes lead of working cross functional teams.
•    Prepares formal documentation of the product designs, change management, risk analysis, product requirements and specifications, customer needs, etc. according to established product development procedures.  Initiates formal reviews to progress projects to compliant completion. 
•    Prepares or coordinates development of design drawings, specifications, estimates of costs, documentation updates, etc. Utilizes appropriate PLM, ERP, and other product-related database systems.
•    Conducts research on projects associated with the design and/or design modifications of medical devices, components, models, or mechanisms.
•    Develops, maintains, and publishes plans for assigned projects with critical milestones and timelines. Owns the change management activities for sustaining or supplier-initiated changes. Leads design transfer activities when required.
•    Develops and coordinates the execution of protocols for validations of new or modified devices or components, including validations of the design, test methods, manufacturing processes, assembly, packaging, and sterilization where applicable.
•    Primary R&D interface with operations for cost improvement projects, vendor materials, and finished goods qualifications.
•    Investigates and resolves technical production problems involving product performance.
•    International efforts (travel, interface) are key, as role supports new product development and sustaining engineering efforts for the manufacturing plants as applicable.  Teleflex is a global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia, India, and Germany.
•    Consults with sales staff or customer on product requirements where design or manufacturing issues or changes are involved.
•    Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.

Education / Experience Requirements

•    Bachelor’s Degree in Engineering
•    Minimum 3-5 years of work experience in the development of devices within the medical device industry. Prior work in testing, validation and/or sustaining engineering is preferred, with close partnerships with manufacturing teams.  
•    Experience in SolidWorks CADD (design/drafting) program preferred
•    Microsoft Office Suite (Project, Word, Excel) required
•    Injection molding, plastic extrusion, plastic part assembly, wound care, hemostatic product experience a plus
•    Experience working within the medical device-related industry requirements (FDA, MDD, MDR, ISO Standards, etc.)
•    Relational database experience (such as Oracle Agile) and ERP experience (SAP, Oracle) a plus
•    Testing experience using ISO and ASTM testing methods for medical devices and general plastic components preferred
•    Principles and practices of professional engineering
•    Regulations pertaining to medical device design and design modifications

Specialized Skills / Other Requirements

Skill Sets:
•    Strong written and verbal communication skills and attention to detail. 
•    Effectively present information and respond to questions from groups of customers, peers, managers, and senior leadership.
•    Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
•    Analyze complex, technical, and administrative problems and adopt an effective course of action.
•    Make effective presentations to, and participate in a variety of meetings and conferences with other companies 
Ability To:
•    Demonstrate creativity and ingenuity in applying engineering principles and practices.
•    Draw solutions from a wider range of experience.
•    Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
•    Conduct comprehensive studies and preparation of reports including recommendations.
•    Prepare clear and concise statements and reports.
•    Establish and maintain cooperative relations with those contracted in the workplace.
•    Speak and write English fluently.

Working Conditions / Physical Demands

•    Typical research and molding lab, office environment, manufacturing areas and some clinical visits.
•    Some exposure to the electrical/mechanical/power manufacturing or testing equipment, with occasional heat and noise exposure and exposure to dust.
•    May be assigned to visit domestic and international sites 

The description above represents the most significant duties of this role but is not all inclusive. Other work assignments comparable to the level of responsibility indicated above may be 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