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Staff Product Development Engineer
The Product Development Engineer is responsible for responding to Requests for Quotes, managing quick turn medical device OEM projects or l, and prototyping catheters and sub-assemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products.
Teleflex Medical OEM is the leading provider of comprehensive product development and production services to medical device manufacturers across the world. We set ourselves apart with deep expertise, decades of experience, and extensive, in-house capabilities, which include engineering, regulatory affairs, design for manufacturability, prototyping and validation, manufacturing, assembly and packaging. Our customers depend on Teleflex Medical OEM to deliver industry-changing innovations and next-generation solutions for precision extrusions, diagnostic and interventional catheters, sheath/dilator sets (introducers), medical balloons, specialty sutures and fibers, and bioresorbable sutures, yarns, and resins.
Develop catheters and catheter sub-assemblies according to customer design, performance, and quality specifications; on time and within budget.
Partner with sales, quoting, customer service and other internal and external stakeholders to meet customer demands
Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverable and milestones
Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
Review and prepare status reports, modify schedules, and project plans as required
Keeps stakeholders, customers, and others informed of project status and/or related issues
Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
Apply design controls from initial customer requests throughout the products life cycle
Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECN, SOP s, BOM s, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation
Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
Address customer s issues: improve performance, appearance, and impact on end-user
Accurately predict project costs, material lead times, and product delivery schedules during the quoting process, and utilize the SAP system to support project needs
Develop bills of materials and assembly method, update SAP, and provide any needed training to technicians and assemblers.
This position requires direct contact with an implantable device. Yes No
Bachelor s degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred, or a related technical field
Master s degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
10 years experience in Medical Device Manufacturing
5 years experience developing medical catheters
SPECIALIZED SKILLS & OTHER REQUIREMENTS: Additional preferred or required qualifications.
Working knowledge of manufacturing processes related to medical device manufacturing
Ability to prioritize and work independently as a self-starter with strong proactive work ethics
Experience with design controls, FDA regulation, GMP practices, and QSR requirements
Proficient in Microsoft Office and Microsoft Project
Excellent working knowledge of GD&T with proficiency in Solid Works
Experience with Risk Analyst tools and procedures
Proven track record in Leadership role and utilizing Project Management
Proven track record in product development, design, and working closely with manufacturing
Demonstrated customer relations, problem solving, and product development skills
Ability to influence across boundaries, drive collaboration, and develop product to meet the end users expectations
Must be well-organized, detail-oriented, with excellent oral and written communication skills
TRAVEL REQUIRED: 15-30 %
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, 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.