Expected Travel: Up to 10%
Requisition ID: 6222
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.
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, the Process Development Engineer II will participate on 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 includes the planning and execution of equipment and process validation, and the transfer of these processes into production for commercial manufacturing. In addition to bringing these products to market, the PD Engineer II will participate the management of our Process Technology Portfolio, identifying and documenting the key technologies that enable The Interventional Product Portfolio.
• Design, characterize and implement manufacturing processes that are robust in meeting design output requirements
• Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader.
• Identify, specify, and coordinate development, sourcing and qualification of equipment, tooling, fixtures and component materials to produce product per design specifications.
• Execute process characterization and investigations to establish process limits.
• Generate documentation as outlined in the Process development process (e.g., PFMEAs, protocols, reports, MPs, Design Transfer reports, etc.).
• Develop and implement documented procedures to provide easy to follow instructions for production of products meeting design specifications and requirements.
• Mentor and direct PD technicians to perform and document equipment qualifications, process characterization and qualification builds.
• Conduct test data analysis including identification of outliers or non-normal data, generating data plots, general statistical analysis, and determining process capability.
• Investigate and troubleshoot process issues, determine causes, recommend, and implement solutions.
• Conduct process design, development, and implementation on multiple projects.
• Coordinate, and execute systematic process development activities such as process characterization, DOE (to establish process limits), qualification and validation builds.
• Accurately document characterization studies, develop validation build records, independently generate OQ and PQ protocol and report documents.
Education / Experience Requirements
• BA/BS in Engineering or physical sciences required.
• 3 years of related experience required.
• Experience with design and process risk management documents (DFMEA/PFMEA) is preferred.
• Familiarity with medical device manufacturing processes is preferred.
Specialized Skills / Other Requirements
• Demonstrated project management skills and ability to coordinate multiple projects simultaneously.
• Capability to perform process qualification and validation activities including risk assessment, range finding, DOE and process documentation.
• General knowledge of Quality System methodologies and regulations associated with the medical device industry.
• Basic understanding of process validation (IQ, OQ & PQ), familiarity 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 be capable of independent problem solving and have sufficient understanding of statistical techniques to perform data analyses and process capability analysis.
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.
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