R&D Engineer

Date: Apr 6, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3549

 

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

The R&D Engineer will be responsible for developing the manufacturing process, inspection procedures, and documentation required to build a medical device.  They will plan and manage the project through inception to customer approval and initial production runs. Most projects last 6-10 weeks, so this role is ideally suited for someone who enjoys a quick paced environment. The R&D Engineer is responsible for responding to requests for quotes and customer interactions, collaborating with a technical team of other engineers, technicians, and operators and interfacing with internal and external development teams, and providing expertise in the design, prototyping, and manufacturing of complex catheters sub-assemblies.  Candidate must be able to work with minimal supervision. 

Principal Responsibilities

•    Collaborate with other development engineers and technicians to develop catheters, balloons, and catheter subassemblies and processes according to customer design, performance, and quality specifications; on time and within budget.
•    Drive strategic and financial initiativesand provide project plans on capability improvements and long-term milestones.
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Hands-on catheter design, development, and assembly with customers, both internal and external
•    Will work with many areas including: complex catheters including steerable catheters, smart catheters, complex shape balloons, handle design, molding, braiding, tipping
•    Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECO, SOP's, BOM's, drawings, IQ, OQ, PQ, FMEA etc...as required to develop, support, or maintain technical documentation
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Coordinate activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Intimately involved in developing protocols, including verification and validation testing, drawings, calculation and/or FMEA etc...to develop and support technical documentation
•    Address customer's issues: improve performance, appearance, and impact on end-user
 

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred. Graduate degree preferred
•    2+ years experience in Medical Device manufacturing
•    Prior experience with Catheter development and manufacturing is preferred.     
•    Design control experience and FDA/CE experience preferred
 

Specialized Skills / Other Requirements

•    Ability to prioritize and work independently as a self-starter with strong proactive work ethics
•    Experience with design controls, FDA regulation, GMP practices, and QSR requirements
•    Proficient in Microsoft Office and Microsoft Project
•    Experience in CAD software (SolidWorks, AutoCAD, etc.) preferred
•    Experience with Risk Analyst tools and procedures preferred
•    Demonstrated customer relations, problem solving, and product development skills
•    Must be well-organized, detail-oriented, with excellent oral and written communication skills
 

 

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: Minneapolis