Expected Travel: Up to 25%
Requisition ID: 5450
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.
Responsible for leading and supporting the execution and oversight of sustaining projects within the OEM Performance Fibers (sutures) business unit. With a focus on projects which support existing products/business such as supplier changes, regulatory and compliance-driven projects, cost improvement projects, process development and improvement, as well as design changes.
Expected to understand principles of Design Control methods, medical device regulations, and project management. Successfully support and carry out project deliverables/sustaining engineering functions with a focus on quality, compliance, and customer satisfaction.
The scope of products for which the Sustaining Engineer will be responsible for supporting includes sterile and non-sterile suture components, contract manufactured suture products, and sterile suture devices for the Mansfield, MA, Coventry, CT, and Nuevo Laredo, MX facilities.
• Support or lead Sustaining projects and project activities ranging from low to high levels of complexity requiring low to moderate levels of guidance from a supervisor or design.
• Draft and route project initiation documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with minimal guidance.
• Effectively interface with cross-functional teams to track project deliverables, responsibility, and progress.
• Coordinate and execute activities supporting Sustaining and Product Development initiatives as well as continuous improvement efforts such as procedure revisions, drawing reviews, creation of guidance documents, etc.
• Apply project management principles such as scope definition, timeline development, contingency planning and risk planning.
• Perform exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation for quoting purposes.
• Review and prepare status reports, modify schedules, and project plans as required.
• Manage stakeholder communication to ensure project status and/or related issues are effectively communicated. Collaborate with sales and customer care to support customer communications.
• Support technical needs and inquiries for Sales, Quality, Regulatory, Marketing and other cross-functional teams.
• Assist in investigating and identifying design control requirements.
• Identify needs for design control or sustaining projects based on product, process and business changes.
• Support the tracking and management of sustaining projects in queue, assisting in identifying potential customer, regulatory, and business impact to establish priority.
• Understand product capabilities to support Performance Fibers projects and initiatives.
• Review and create product/customer specification documents based on internally validated specifications and inspection criteria.
• Generate validation and verification protocols/reports, draft and review product labeling, initiate and manage sterility and biocompatibility assessments as well as other design control-related documents.
• Ensure Teleflex Medical OEM suture products meet customer and quality system requirements.
• Support root cause analysis investigations and customer or project-related problem resolution activities.
• Coordinate and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) as well as other technical documentation.
• Ensure projects are developed and documented compliant with the Quality System.
• Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
• Support, lead and participate in design control reviews with guidance as needed.
• Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
• Employ an entrepreneurial spirit and mindset to support growth of the team and business.
• All other duties as assigned.
Education / Experience Requirements
• Bachelor of Science in Engineering or related technical discipline.
• Minimum of 4 years of experience in medical device, regulated industry, or related field.
Specialized Skills / Other Requirements
• Strong interpersonal skills that include working well in a team environment with the ability to effectively manage tasks and team activity.
• Effective written and oral communication skills.
• Ability to communicate technical information in a technical and non-technical manner.
• Focus on detailed work with emphasis on accuracy and completeness.
• Exercises discretion and independent judgment.
• Strong organizational and planning skills; drives for results.
• Effective analytical/problem-solving skills.
• Ability to handle multiple tasks and to prioritize/schedule work to meet project needs.
• Experience with Microsoft Office - PC, Word, Excel, PowerPoint.
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.
© 2021 Teleflex Incorporated. All rights reserved.
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