Date: Jul 29, 2019
Location: Mansfield, MA, US
Expected Travel: Up to 10%
Requisition ID: 1248
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.
OEM Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
This position is responsible for the creation, execution and development of medical device documentation including manufacturing related processes. Maintaining the quality of the suture Products portfolio in order to maintain viability and compliance with regulatory and environmental requirements while addressing product obsolescence, supplier disruption and other manufacturability and engineering challenges. Responsible for ensuring the sustainability of the Performance fibers business by managing and implementing material changes in a timely manner within the Teleflex Quality systems.
Creates and modifies manufacturing documentation such as BOM's, routers, drawings and procedures.
Prepare ECO documentation for manufacturing/R&D for 3 sites.
Creates and reviews newly created documentation to ensure accurate information transfer to the manufacturing floor for 3 sites.
Executes the creation of customer specifications to internal specs for product development and manufacturing purposes.
Revises drawings, procedures, and forms to capture required changes (ie ISO, FDA, Corporate)
Updates and works with engineering on changes needed to specifications, dwgs or labels
Create appropriate documentation for customer samples to ensure specifications are met.
Supports all areas of the organization including R&D, Sales, manufacturing, Quality and Customer Service in order to meet customer requirements, on time delivery and Teleflex corporate metrics.
Participation in the overall product development program management system including regular meetings and discussions around project priorities, status updates
Assists in the development of solutions that will target manufacturability, cost structure, quality, reliability, and overall effectiveness for 3 sites
Initiate and lead new product line extensions as it relates to the addition of currently developed and approved products.
Education / Experience Requirements
Minimum of highschool diploma or GED required.
Associates/Bachelors degree preferred.
3+ years of relevant experience working in documentation preparation and coordination. Experience in a manufacturing environment preferred (medical device manufacturing a plus).
Specialized Skills / Other Requirements
Strong computer skills including Microsoft Office, Word, Excel, Outlook.
Strong working knowledge of and ERP system required; SAP preferred.
Strong written and verbal communication skills
Well developed problem solving and analytical skills
Strong planning and organizational skills
Ability to prioritize work. Sense of urgency to meet deadlines
Customer focused and service oriented
Ability to manage and prioritize workload
Ability to work within a team as well as independently
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, Rsch, UroLift and Weck trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.