Teleflex

Position Summary The Senior Development and Sustaining Engineer is responsible for the development and maintenance of respiratory, anesthesia, and/or urological products. Under minimal direction, the incumbent will organize and manage multiple projects and ensure they are completed in a timely manner, create design ideas for new products, and develop creative solutions to existing products when problems arise or modifications are requested. Principal Responsibilities Conduct research and/or development projects associated with the design and/or modification of medical devices, components, models, or mechanisms. Prepare or coordinate formal documentation of the product designs, risk analysis, product specifications, market specifications, etc. according to established product development procedures. Initiate formal reviews to get approvals per procedures. Develop, maintain and publish product development plans for assigned projects with critical milestones and timelines. Develop and coordinate the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable. Investigate and resolve technical problems involving product performance, production equipment, or facility systems affecting production. Coordinate the product design and development process with appropriate support departments such as engineering, regulatory, documentation, tooling, and manufacturing. Serve as project leader for assigned projects and follow up on all aspects of projects, including conducting reviews with support groups and outside resources where applicable. Prepare or follow up on preparation of design drawings, specifications, estimates of costs, mainframe updates, etc. Discuss and consult with sales staff or customer on product requirements and specifications where design or manufacturing problems are involved. Work with manufacturing in the justification and the selection of the manufacturing process. Assign projects and establish priorities to ensure datelines and goals are achieved. Develop assembly methods and procedures. Create engineering draws and specifications. Coordinate changes in process, tolling, and equipment identified to positively impact the manufacturing process, while staying within GMP guidelines. Coordinate the reporting on project status for all responsible projects. Direct reports in formal periodic project review meetings, to include cost reduction progress, capital spending, and expense status. Enhance personal growth and development through participation in education programs, current literature, training meetings and workshops. Participate actively in continuous quality improvement activities through compliance with safety standards. Demonstrate professional responsibilities by cooperating with other personnel to achieve department and interdepartmental goals and objectives and maintain good employee relations. Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department. Analyze complex, technical and administrative problems and adopt an effective course of action. Conduct comprehensive studies and preparation of reports including recommendations. Make effective presentations to, and participate in, a variety of meetings and conferences with other companies and the public. Prepare clear and concise statements and reports. Education / Experience Requirements Bachelor s degree in Biomedical Engineering or closely related field. Possession of BS degree may be substituted for six (6) additional years of work experience in the design and/or modification of plastic components for the medical industry 5+ years experience in product development 3+ years experience leading medical device engineering projects Experience with injection molding, plastic extrusion and plastic part assembly process and methods required Experience with CAD (design/drafting) programs, including SolidWorks, preferred Specialized Skills / Other Requirements Solid understanding of and experience with: U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices. ISO and ASTM testing methods for medical devices and general plastic components Principles and practices of professional engineering. Regulations pertaining to medical device design and design modifications. Demonstrated creativity and ingenuity in applying engineering principles and practices and drawing solutions from a wide range of experience. Effective written and oral communication skills and ability to present information to, and respond to questions from, various audiences. Ability to interpret and follow instructions furnished in written, oral, diagram, or schedule form. Intermediate knowledge of Microsoft Office Suite (Project, Word, Excel, and Access) Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Proven ability to establish and maintain effective working relationships with peers. Working Conditions / Physical Demands Typical research lab and office environment; occasional work in manufacturing areas and some field work. Some exposure to the electrical/mechanical/power manufacturing or testing equipment, with occasional heat and noise exposure and exposure to dust. May visit domestic and international (Mexico, Asia) manufacturing sites. Travel required up to 10%. Associated topics: boiler, catia, mechanical, mechanism, motor, powertrain, proe, rotordynamic, turbine, vibration

Position Summary This Morrisville, NC based lab tech position supports the Research and Development Engineering team by conducting finished product and / or component evaluations in accordance with internal procedures, as well as domestic and international standards for product qualification, verification, and validation. The role interfaces not only with the supervisor of the team, but also members of the engineering staff on projects in various levels of the product lifecycle, from pre-launch testing and analyses to current products. Principal Responsibilities Provide controlled lab testing of Teleflex products and competitor s products; evaluations of functionality and reliability and support validations of new and existing products and processes. Inspect and measure parts Tests and documents returned customer complaints as required by Marketing and Customer Support Groups. Performs reliability and functionality testing. Evaluates existing products and materials, competitor products and vendor products. Assists to develop uniform product evaluation protocols, procedures, test methods, test report forms and reports, and non-destructive test methods. Follows test procedures and provides documented results in the form of spreadsheets and lab report. Perform problem investigation and participate in team problem solving Design and develop test fixtures and methods in accordance to ASTM, ISO, etc. guidelines Conforms to the 5S principles and all QSR/ISO housekeeping requirements of the department. Education / Experience Requirements A high school diploma is required; an associate s degree is preferred, and a baccalaureate degree in engineering or related fields is a plus. The chosen candidate must offer also extensive laboratory experience, ideally in medical device. Other applicable experience areas could include quality assurance and quality testing laboratories Specialized Skills / Other Requirements Understanding engineering drawings is essential. A team player who is self-motivated, able to take initiative, and able to effectively prioritize work for self and group. Strong verbal and written communication skills. Speaks/writes English (essential). A strong desire to help create a positive, winning, world-class working environment. Familiarity with GLP, GMP, and FDA design controls Prepare and maintain concise and complete records and reports. Operate small tools, hand tools, measurement gauges, and fixtures Operate automatic and manual machines that repair and test medical equipment parts and components, e.g. Force, Burst testers, etc. Understand and communicate machine and component problem to support personnel and continuously monitor equipment and product produced. Perform routine preventative maintenance and minor repairs using simple tools while working from instructions. Keep abreast of developments in area of repair and test of medical equipment parts and components. Experienced with Microsoft Office, especially Excel and Word. Experienced with vision measurement systems Experience with various measuring devices such as Instron, flow meters, pressure gauges, scales, temperature probes, etc.

Position Summary The Clinical Sales Specialist will be responsible for the promotion of the safe and effective use of Teleflex s new breakthrough product for large bore closure. The Clinical Sales Specialist role will be instrumental in driving adoption, utilization, and sales revenues by providing superior sales support, case coverage and product education to both customers and sales representatives. Principal Responsibilities Provide sales and/or clinical support to promote and sell Teleflex s large bore closure product. Effectively deploys clinically relevant product features / benefits and economic justification using existing selling tools to each customer situation to define the value of our product offerings. Conduct product demonstrations and in-services to physicians and other medical personnel to educate them on the safe and effective use of the product. Provide case coverage for physicians conducting product evaluations and first cases with products as they move to becoming consistent users and customers. Develop and implement a proactive plan that involves sales and/or clinical support with the Regional Sales Manager and team members, to achieve sales goals and increase the quality of service to customers. Work closely with the Regional Sales Manager and sales representatives in evaluating business conditions and sales trends. Work with Marketing, R&D, and Clinical Medical Affairs team to provide ongoing education and training updates, field intelligence on competitive products, market activity, effective clinical support techniques, as well as input on customer preferences and product features. Comprehensive product knowledge with the ability to utilize sales techniques in a clinical setting. Support Cardiology conferences and Society meetings, workshops, and other marketing events as requested scheduled by management. Work in the Interventional Cardiology or Interventional Radiology lab on a day to day basis to drive evaluations, adoption and use of product throughout assigned area. Facilitate resolutions to customer questions or complaints. Build robust relationships with medical staff. Complete necessary reports and administrative tasks as needed (i.e. expense reports, competitive updates, sales force.com). Manage time and asset costs effectively. Regional travel as necessary to support the needs of the business. (approximately 50% travel) Perform other duties as requested. This may include (but not limited to) supporting Teleflex s complex PCI portfolio. This position requires direct contact with an implantable device. Yes No Education / Experience Requirements Bachelors degree preferred. Associate Degree and a minimum of 3 years of Cardiac Catheterization Lab experience. Experience of working in Cath labs with any of the following product lines; Structural heart products, Aortic Valve replacement any other product-related to femoral arteries or closure of arteries. Experience with complex PCI strongly preferred. Self-directed, able to work independently, and ability to handle multiple projects concurrently & function in a fast-paced, high growth environment. Previous sales experience strongly preferred. Strong problem solving/analytical skills and effective presentation skills. Excellent organizational skills, strong communicative, problem solving, and interpersonal skills are required. Proficiency with computer technology and Microsoft Office tools, including iPhone and Ipad platforms. Specialized Skills / Other Requirements Ability to deliver complex and technical subject matter to clinicians in a hospital or clinical setting. Ability to handle difficult conversations/situations. Possess excellent communication, customer service, and presentation skills. Stand, walk, or sit in meetings or with customers for 6 -- 10 hours per day, up to five (5) days per week. Interact with others through effective, verbal and written communication. Possess a valid driver s license and operate a motor vehicle with satisfactory driving record. Carry detail bag weighing up to 20 lbs. Lift equipment weighing up to 30 lbs. Strong interpersonal skills while discussing products and procedures with customers. Meet all vendor credentialing requirements. TRAVEL REQUIRED : 50 % Associated topics: field service, install, microsurgery, physician, sales engineer, solution engineer, spinal, technical, vascular, web service

Position Summary The Clinical Sales Specialist will be responsible for the promotion of the safe and effective use of Teleflex s new breakthrough product for large bore closure. The Clinical Sales Specialist role will be instrumental in driving adoption, utilization, and sales revenues by providing superior sales support, case coverage and product education to both customers and sales representatives. Principal Responsibilities Provide sales and/or clinical support to promote and sell Teleflex s large bore closure product. Effectively deploys clinically relevant product features / benefits and economic justification using existing selling tools to each customer situation to define the value of our product offerings. Conduct product demonstrations and in-services to physicians and other medical personnel to educate them on the safe and effective use of the product. Provide case coverage for physicians conducting product evaluations and first cases with products as they move to becoming consistent users and customers. Develop and implement a proactive plan that involves sales and/or clinical support with the Regional Sales Manager and team members, to achieve sales goals and increase the quality of service to customers. Work closely with the Regional Sales Manager and sales representatives in evaluating business conditions and sales trends. Work with Marketing, R&D, and Clinical Medical Affairs team to provide ongoing education and training updates, field intelligence on competitive products, market activity, effective clinical support techniques, as well as input on customer preferences and product features. Comprehensive product knowledge with the ability to utilize sales techniques in a clinical setting. Support Cardiology conferences and Society meetings, workshops, and other marketing events as requested scheduled by management. Work in the Interventional Cardiology or Interventional Radiology lab on a day to day basis to drive evaluations, adoption and use of product throughout assigned area. Facilitate resolutions to customer questions or complaints. Build robust relationships with medical staff. Complete necessary reports and administrative tasks as needed (i.e. expense reports, competitive updates, sales force.com). Manage time and asset costs effectively. Regional travel as necessary to support the needs of the business. (approximately 50% travel) Perform other duties as requested. This may include (but not limited to) supporting Teleflex s complex PCI portfolio. This position requires direct contact with an implantable device. Yes No Education / Experience Requirements Bachelors degree preferred. Associate Degree and a minimum of 3 years of Cardiac Catheterization Lab experience. Experience of working in Cath labs with any of the following product lines; Structural heart products, Aortic Valve replacement any other product-related to femoral arteries or closure of arteries. Experience with complex PCI strongly preferred. Self-directed, able to work independently, and ability to handle multiple projects concurrently & function in a fast-paced, high growth environment. Previous sales experience strongly preferred. Strong problem solving/analytical skills and effective presentation skills. Excellent organizational skills, strong communicative, problem solving, and interpersonal skills are required. Proficiency with computer technology and Microsoft Office tools, including iPhone and Ipad platforms. Specialized Skills / Other Requirements Ability to deliver complex and technical subject matter to clinicians in a hospital or clinical setting. Ability to handle difficult conversations/situations. Possess excellent communication, customer service, and presentation skills. Stand, walk, or sit in meetings or with customers for 6 -- 10 hours per day, up to five (5) days per week. Interact with others through effective, verbal and written communication. Possess a valid driver s license and operate a motor vehicle with satisfactory driving record. Carry detail bag weighing up to 20 lbs. Lift equipment weighing up to 30 lbs. Strong interpersonal skills while discussing products and procedures with customers. Meet all vendor credentialing requirements. TRAVEL REQUIRED : 50 % Associated topics: architect, building, engineer, install, installation, lab, microsurgery, physician, sales engineer, vascular