This position will provide senior level project management leadership for the MicroLaparoscopy product platform within the Surgical Business Unit. The Micro Laparoscopy platform is a foundational building block of the SBU’s 5-year strategic objectives, and represents a new and innovative alternative to traditional multi-port laparoscopy. The candidate will perform duties to assure critical platform requirements are established and met within a defined timeframe established between external suppliers and strategic product development partners and internal New Product Development, manufacturing and operations. This position requires significant cross-cultural capabilities and skills, including an ability to understand cultural customs and have a keen awareness of the nuances of native communications. This position may require long periods of travel, including international. This individual must be an effective communicator with a proven background in organizational influence and effectiveness. The ideal candidate should possess a comprehensive working knowledge of medical device products, mechanical and electro-mechanical designs, materials, regulations and manufacturing operations. In addition, the ideal candidate will have experience in the development through and including the commercialization of medical devices in the U.S. and abroad.
Teleflex is a medical device company specializing in General, Cardiovascular, ENT and Orthopedic instrumentation as well as ACT2 container systems. Our premier brands include Pilling, Weck, and KMedic. Teleflex also offers N-COMPASS™, a software-based Instrument Management System.
•Lead cross-functional teams in the management of essential deliverables in the external and internal development of various medical devices in a new product platform.
•Develop high level project guidance documentation for all project participants to utilize. Develop/participate in the generation of modifications to standard department practices to accommodate the requirements associated with new product lines.
•Represent the business unit as a professional business liaison for the purpose of new product development involving various strategic development partners.
•Participate in building an appropriate team to address the resource requirements for an assigned development project and/or department needs. Provide input and/or critique the performance of team members as requested by immediate supervisor.
•Effectively lead and manage the respective development teams’ time and progress toward major milestone events. Lend guidance to respective development teams to address specific design documentation requirements and monitoring that the technical progresses in agreement with high level design document requirements.
•Maintain a comprehensive understanding of the Voice-of-Customer requirements as provided by the designated Manager of Strategic Product Development and the Global Marketing Manager.
•Facilitate the practices required to comply with Good Manufacturing Practices (GMP) and applicable International Standards (ISO-9000). Provide statistical support on a consulting basis to the corporation.
•Interface with manufacturing and engineering personnel to develop new tooling, machinery, and processes as required. Verify that developed processes can meet technical, cost, and reliability targets established for the project.
•Train and assist new individuals in product design development, documentation, and manufacturing related processes.
•Participate as required with senior management representatives to critique new opportunities associated with areas of expertise.
•Remain current with all internal and appropriate external developments and policies in related areas of activity.
•Provide other department support as requested by immediate supervisor or senior management.
•Will supervise a minimum of one Design Engineering professional.
•Strong analytical and problem-solving skills and comprehensive understanding of design control. processes and validation of processes and designs.
•Proven project management skills.
•Experience in international development and markets.
•Effective verbal, presentation and written communication skills.
•Excellent interpersonal skills with demonstrated leadership, organizational influence and decision making competencies.
•Proven ability to direct, lead and influence dotted line and shared service personnel.
•Proficient in Microsoft Office Suite, Solidworks and Pro Engineer.
•Working knowledge of medical device development, sterilization requirements and techniques.
•Prefer Masters level degree in Engineering / Technology.
•At least 7-10 years of Project Management experience in a regulated industry, preferably medical devices.
•At least 7-10 years of relevant experience in engineering field related to product development, process development or manufacturing, with emphasis in general surgery and related instruments.
•International experience and/or experience with third-party or joint-venture development of medical devices, preferred.
•Experience in the commercialization of surgical medical devices in the U.S. and global, is preferred.
•Prefer experience in working with cross-cultural entities, understanding of cultural customs and proven ability to navigate the challenges of global communications.
•General and business economics and administration, as well as the special techniques for the planning, direction, and control of scientific and technical project work.
•A comprehensive working knowledge of medical device products, mechanical and electro-mechanical designs, materials, regulations and manufacturing operations is required.
•Working knowledge of budgets, business drivers and metrics.
•Comprehensive understanding of ISO, GMP and FDA regulations for the development.
Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.
Teleflex Medical - 21 months ago
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