R&D Engineer

Position Summary

As part of the Anesthesia & Emergency Medicine Business Unit and in the Research & Development team, the R&D Engineer in our Morrisville site is responsible for the development of medical devices used in the Airway product portfolios. Experience should focus on Research and Development of Medical Devices. Incumbent organizes and drives multiple projects and insures phases are completed in a timely manner; creates design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested. Products will include all classifications, i.e. Class I, IIa, IIb and III.  The medical device products sold in the business unit include airway, pain management and mucosal atomization products.

Principal Responsibilities

•    Executes projects associated with the design and development of medical devices from concept to commercialization.
•    Works with marketing, clinical, sales staff and customers to define and refine product requirements and specifications.
•    Develops knowledge through competitor breakdowns, literature reviews and Intellectual property research.
•    Works across R&D development teams for SMEs and additional resource support by project/phase.
•    Develops partnerships within Teleflex engineering network across departments and business units, and utilizes accordingly.
•    With an entrepreneurial mindset, develops concepts, porotypes and corresponding test methods for rapid development cycles.
•    Acts as project lead and/or technical lead to develop, maintain and present development plans with critical milestones costs and timelines.
•    Develops approved DHF/DMR documentation including, User Needs, Design Controls, Risk Analysis, Product Specifications, and Process or Design changes.
•    Develops and coordinates/performs execution of protocols for the V&V activities for new and existing products.
•    Works with procurement, operations and external vendors to develop a robust high value product supply chain and to identify opportunities to improve.
•    Demonstrates professional responsibilities by cooperating with other personnel to achieve department goals while making it fun for all involved.
 

Education / Experience Requirements

•    Bachelor of science degree required in Engineering (biomedical or mechanical preferred); a professional engineer certification is a plus.  Two to five years of professional work experience in the design of devices are expected.
•    Experience in SolidWorks CADD (design/drafting) program required.
•    Microsoft Office Suite, (Project, Word, Excel and Access)
•    Mechanical and or mechatronic acumen preferred.
•    Experience in U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices strongly preferred.
•    ISO and ASTM testing methods for medical devices and general plastic components preferred.
•    Ability to travel domestically and internationally.
•    Demonstrate creativity and ingenuity in applying engineering principles and practices.
•    Organize, evaluate, and coordinate engineering studies with professional, technical, and support staff of a product evaluation department.
•    Establish and maintain cooperative relationships with those contacted in the course of work.
•    Prepare clear and concise statements and reports.
•    Speak and write English fluently.
•    Self-motivated people person who thrives on a challenge.
 

Specialized Skills / Other Requirements

•    Effectively present information and communicate with all including peers, managers, customers, and the general public while always Building Trust.
•    Solve challenges and deal with a variety of concrete variables in situations where only limited standardization exists. 
•    Analyze complex, technical and administrative problems and adopt an effective course of action.
•    Form positive relationships which result in better project outcomes and make Teleflex a great place to work.