Principal Process Development Engineer

Date: Sep 10, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4655

 

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

•    To develop and document manufacturing processes capable of producing products meeting design specifications and cost targets in a timely and efficient manner.
•    To plan, coordinate, and execute process validations and transfer validated processes and equipment into production for commercial manufacturing.
•    Coordinating with production to produce initial finished goods inventory for new product launches.
 

Principal Responsibilities

•    Manage the design, development and implementation of new production equipment, processes and verification methods. 
•    Manage the planning, execution and documentation of all process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets. 
•    Develop project plans, establish timelines and budgetary estimates, track progress and communicate project status to management and project leader.  
•    Manage projects to achieve on time and within budget project deliverables for multiple projects simultaneously.  
•    Identify, specify and coordinate development, sourcing and qualification of: equipment, tooling, fixtures and component materials to produce product per design specifications.
•    Actively pursue process and equipment improvements to improve process reliability and minimize product manufacturing cost
•    Develop and implement documented procedures to provide easy to follow instructions.
•    Write, review and approve technical protocols, reports, and data as outlined in the Process development process (e.g. PFMECAs , protocols, reports, MPs, Design Transfer reports, etc.) 
•    Direct PD Engineers and Technicians on performing; equipment qualifications, process characterization and qualification builds.
•    Manage and conduct test data analyses including: identification of outliers or non-normal data, and determining process capability. 
•    Conduct Risk Analyses, Failure Analyses and Root Cause investigations and report results
•    Train PD Engineers, PD technicians, production operators and manufacturing technicians
•    Directly manage and mentor PD Engineers and/or  PD Technicians 
•    Conduct process design, development, and implementation on multiple complex &/or significant VSI projects. 
•    Coordinate, direct, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds
•    Identify, propose, pursue, and implement improvement opportunities which align with business objectives. 
•    Identify and pursue continuous improvement opportunities to improve manufacturing or business process efficiency. 
•    Interview, select, train and evaluate performance of new hires to staff the department with motivated and skilled professionals. 
 

Education / Experience Requirements

•    Bachelor degree in Engineering discipline
•    8 years of related experience required
•    Experienced working in regulated development or manufacturing environment 
•    Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle 
 

Specialized Skills / Other Requirements

•    Expertise in project management with the ability to coordinate multiple projects simultaneously
•    Experienced in process qualification and validation activities including risk assessment, range finding, DOE and creation of process documentation
•    Extensive knowledge of GMP and QSR including Design Control and Process Validation. 
•    Proficiency in MS Office applications, strong written and verbal communication skills, ability to read and understand technical drawings, product requirements and specification documents 
•    Excellent analytical and problem solving skills, familiarity with statistical techniques, experience with scientific methods and Design of Experiments.
•    Experience with common disposable medical device manufacturing processes (e.g. molding, reflow, coating, bonding, and / or 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