Design Assurance Engineer

Date: May 2, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3859

 

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 position’s responsibility is for supporting all aspects of the design control business in the OEM division. The position supports our OEM development team in the design of highly complex medical devices.  They ensure that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and help to ensure successful transfer of the design to manufacturing.  
This position is responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance. They also help collaborate with the other team members in the full design, development, testing, and documentation required for bringing a medical device to market. This is a unique opportunity to work across multiple catheter projects and help bring to market several cutting-edge technologies. 
 

Principal Responsibilities

The Design Assurance Engineer is responsible for supporting customer interactions, collaborating with a team of engineers, technicians, and operators, defining and driving strategic initiatives through market intelligence and interfacing with internal and external development teams, and providing expertise in the design, prototyping, and manufacturing of complex catheters.  The candidate must be able to work with some supervision in a fast-paced and be comfortable in leading teams and managing projects. 

The position is ideally suited for a candidate with a robust knowledge of design controls (21CFR 820), R&D, and process development. A strong working knowledge of all risk (ISO 14971), and testing standards (ISO 10555, ISO 10993, etc.) are also important in this role. This role will focus on documentation and testing and collaborate with an R&D, Quality, and Operations team to help bring new devices to market. 

•    Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECO, SOP's, BOM's, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation
•    Have experience with process validations (IQ, OQ, PQ), as well as test method development and test method validations  
•    Participate and lead-design reviews
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
•    Oversees and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Accurately predict project costs, material lead times, and product delivery schedules during the quoting process.
•    Have some experience in root cause analysis, and resolve customer or project-related problems; materials, assembly, functional, or manufacturing related
•    Performans other functions as required
 

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred. Graduate degree preferred
•    2-6 years experience in Medical Device manufacturing
•    Design control experience and FDA/CE experience required
•    Prior experience with Catheter development and manufacturing is preferred.     
 

Specialized Skills / Other Requirements

•    Deep understanding of the medical device product development pathway and a drive to execute on strategic business objectives
•    Ability to prioritize and work independently as a self-starter with strong proactive work ethics
•    Experience with design controls, FDA regulation, FDA submissions, GMP practices, Audits, and QSR requirements highly preferred
•    Proficient in Microsoft Office and Microsoft Project or other Project management tools
•    Expertise in CAD software (SolidWorks, AutoCAD, etc.) preferred
•    Experience with Risk Analyst tools and procedures
•    Strong experience in contributing in medical device development through FDA/CE submission preferred
•    Demonstrated customer relations, problem-solving, and product development skills
•    Ability to influence across boundaries, drive collaboration, and develop product to meet the end-users expectations
•    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