Senior Process Development Engineer
TeleflexAbout the role
Expected Travel: Up to 10%
Requisition ID: 12266
About Teleflex Incorporated
As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.
Interventional Urology – The Interventional Urology business unit of Teleflex is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. Our flagship product, the UroLift® System, is the #1 minimally invasive procedure in the U.S. for treating an enlarged prostate, also called Benign Prostatic Hyperplasia, or BPH.* It is a proven approach that does not require heating, cutting, or destruction of prostate tissue.1 Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
*U.S. 2022 estimates based on US Market Model 2022-24 (5-17-22 FINAL), which is in part based on data provided by Symphony Health PatientSource® 2018-21, as is and with no representations/warranties, including accuracy or completeness.
1. Roehrborn, Can J Urol 2017
Position Summary
Join our dynamic Interventional Urology business unit, where your expertise will play a pivotal role in shaping the future of healthcare. As a key contributor, you will help develop groundbreaking technologies that enhance patients' lives and empower healthcare professionals.
As a member of the development team, the Senior Process Development Engineer will participate in New Product Development projects by developing robust manufacturing processes for new products across our core portfolios.
Utilizing first-principles thinking and data-driven decision-making, they will ensure these processes produce products that meet design specifications and cost targets. Responsibilities include but are not limited to planning and execution of equipment and process developments. Transfer of processes into production for commercial manufacturing. In addition to bringing these products to market, the Senior Process Development Engineer will participate in exploratory new technology investigation, design and development to help fuel the Interventional R&D product pipeline.
Principal Responsibilities
• Plan process development & validation activities for new products based on projected product volume, project timelines, and COGS targets.
• 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
• Identify, specify and coordinate development, sourcing and qualification of equipment, tooling, fixtures and component materials to produce product by design specifications.
• Work closely with the R&D team, if necessary, help with product development work.
• Execute process characterization and investigations to document key process inputs and outputs and to establish process limits.
• Generate documentation as outlined in the Process Development process (e.g. PFMECAs, protocols, reports, MPs, Design Transfer reports, etc.)
• Leading the process verification and validation activities.
• Design and develop fixtures and automation as needed.
• Direct 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 Technicians
• Conduct process design, development, and implementation on multiple complex &/or significant projects.
• Develop and implement documented procedures to provide easy to follow instructions.
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