Expected Travel: Up to 25%
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.
Surgical - Whatever the latest surgical breakthrough looks like, Teleflex is working to make it happen. From our MiniLap® Percutaneous Surgical System to Weck® Hem-o-lok® Polymer Locking Ligation System, and Weck EFx® Shield™ Fascial Closure System, our portfolio of products adds up to a powerful offering of solutions that helps improve patient outcomes. These innovative, minimally invasive surgery products are offered alongside time-tested and trusted Pilling® Surgical Instrument and Lightsource solutions to provide a comprehensive set of solutions to meet the challenges of an evolving healthcare environment. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
The Principal R&D Manufacturing Engineer - Surgical champions the manufacturability of Surgical products from product design through the manufacturing process and is accountable for the practical application of design for manufacturing principles on the product/process development efforts. This position is also responsible for the formalization, coordination and implementation of product test strategies into manufacturing. The Principal R&D Manufacturing Engineer - Surgical is responsible for the manufacturability in the design and development of complex products and production lines. This is a hands-on position for a motivated engineer and talented innovator. The role includes development of manufacturable Surgical products and robust manufacturing processes. The role requires working with internal and external stakeholders to design and specify manufacturable product designs along with tooling and fixturing for the assembly of medical devices.
The following statements describe the principal functions of this job and its scope of responsibility but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties assigned, including working in other functional areas to cover absences or relief to equalize peak work periods or otherwise to balance the workload.
• Work as part of the Surgical R&D product development team to bring new Surgical products to market on time; in budget and within predetermined specifications.
• Is a core team member on the Surgical product development process (PDP) teams representing new product development manufacturing and is accountable for leading manufacturing core teams during the different PDP phases.
• Accountable for key deliverables within the (PDP) including but not limited to Mfg Plan; Make/Buy decision analysis/recommendation; Capacity Planning; COGS estimation; Process Validation; Prototype Builds; Capital Equipment Specifications and Procurement; Design Transfer, etc.
• Responsible/contributor for activities and tasks within the PDP.
• Develop and/or specify integrated motion control systems for manufacturing equipment
• Is a consultant on inquiries posted by team members related to manufacturing and testing technologies or other operations related processes.
• Accountable for the application of Design for Excellence (DFX) principles such as DFM/A; DFC; DFQ; DFT.
• Application of methodologies such as Six Sigma and LEAN to identify, validate and improve defect sources in a variety of processes.
• Application of risk management methodologies such as DFMEA and PFMEA to identify actions that can be taken to eliminate or reduce the potential causes leading to failures.
• Work within Surgical R&D and with supplier quality and procurement to identify and manage contractors.
• Accountable for the development of product and component test strategies interfacing with the receiving manufacturing site.
o Understanding receiving plant test capabilities
o Evaluating any potential for contracting test fixture development
o Driving test strategy realization and schedule with receiving plant
• Adhere to SOP's and have the ability to prepare written policies, procedures, proposals, and reports in accordance with cGMP/FDA/ISO-13485 guidelines and regulations.
Education / Experience Requirements
• Bachelor's degree in Engineering field, Mechanical/Electromechanical preferred or equivalent experience maybe considered in lieu of degree.
• Minimum 10-15 years of progressive engineering experience within a highly regulated industry (i.e. medical device, aerospace or defense) with a minimum of 5 years focused on Manufacturing
Specialized Skills / Other Requirements
• Strong record of manufacturing (mfg) operations management experience including
o Mfg. process management involving a collection of technologies and methods used to define how products are to be manufactured.
o End-to-end manufacturing process involving production management, performance analysis, quality and compliance.
• Manufacturing engineering experience in a medical device related industry, with a demonstrated track record of developing processes for new products.
• Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
• Experience with industrial engineering processes including takt/cycle times estimates, process flow, line layout, capacity planning.
• Project Management of manufacturing process from concept to delivery.
• Strong Mechanical Aptitude (aptitude for understanding and using machines and/or tools).
• Experience with Six Sigma/Lean principals
• Ability to prepare written policies, procedures, proposal, and reports.
• Knowledgeable in risk management methodologies such as DFMEA and PFMEA.
• Knowledgeable in manufacturing plant test strategies.
• Hands on experience with manufacturing equipment design and builds, including but not limited to, electromechanical design, wiring layouts and schematics, PLC Programming (Allen Bradley, Automation Direct) or other motion control programs desired.
• Experience writing and performing IQ/OQ/PQ
• Experience with Solidworks or other CAD software desirable
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.
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