Principal Process Development Engineer, MDR

Date: May 11, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 6288

 

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.

 

Interventional - The Interventional business unit at Teleflex offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We place a strategic emphasis on complex coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our current Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. 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 Interventional R&D group brings a diverse range of new and innovative products to market to meet the needs of our customers in the Coronary, Peripheral, Mechanical Circulatory Support and Structural Heart spaces.  The products we develop are used by physicians around the world to treat disease and restore patients' quality of life.

As a member of the Process Development team, this position will provide Process Development expertise to the planning and execution of the Interventional Business Unit’s EUMDR program.  Working with colleagues in Sustaining, Project Management, Design Assurance and Operations, the Principal Process Development engineer ensures that design outputs are appropriately assessed through process risk documentation and that process validation activities are completed in accordance with current Teleflex quality system requirements. Responsibilities include preliminary gap assessment to establish project scope, management and communication of changes in scope, and the planning and execution of equipment and process validation.  

This role will provide supervision of a team of engineers executing Process Development activities for EUMDR remediation across several programs.  Prior experience supervising others and project/program management experience are highly desired.
 

Principal Responsibilities

•    Evaluate process development & validation deliverables for portfolio products for compliance to current quality system requirements 
•    As needed, plan and guide the execution of Process and Equipment Characterization and Validation activities to remediate gaps in legacy product portfolios to meet current quality system requirements
•    Working with Project Management, establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader.  Manage tasks and deliverables for multiple projects simultaneously
•    Evaluate equipment, tooling, fixtures and component materials for their ability to produce product per design specifications and compliance to the quality system.
•    Evaluate process characterization and investigations for documentation of key process inputs and outputs and to verify that appropriate process limits have been established
•    Direct R&D technicians in performing- equipment qualifications, process characterization and qualification builds.
•    Conduct test data analyses including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determination of process capability. 
•    Lead or participate in Failure Analysis, Root Cause investigation, and identification and verification of corrective actions.  Report results to project and functional leadership
•    Train PD technicians, production operators and manufacturing technicians
•    Mentor and direct PD Engineers and Technicians 
 

Education / Experience Requirements

•    Bachelor's Degree in Engineering or physical sciences required

•    7 years of related experience required

Specialized Skills / Other Requirements

•    Successful track record of process selection, development, and transfer into commercial production
•    Experienced in process qualification and validation activities including risk assessment, range finding, DOE and creation of process documentation
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously
•    Excellent knowledge of GMP and QSR including Design Control and Process Validation. 
•    Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle 
•    Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents 
•    Must have strong independent problem-solving skills and solid understanding of statistical techniques to perform data analyses and process capability analyses (familiarity with statistical software such as Minitab preferred)
•    Excellent analytical and problem solving skills, experience with scientific methods and Design of Experiments.
•    Preferred: 5 years of experience in medical device production or product development. 
•    Preferred: Experience with common disposable medical device manufacturing processes (e.g. molding, reflow, coating, bonding, packaging). 
 

 

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