Associate Sustaining Engineer
Teleflex

Expected Travel: Up to 25%

Requisition ID:4551

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.

Position Summary

The Associate Sustaining Engineer is responsible for supporting the execution and oversight of sustaining projects within the OEM Performance Fibers (sutures) business unit. With a focus on projects which support exisiting products/business such as supplier changes, regulatory and compliance driven projects, cost improvement projects, process development and improvement, as well as design changes, they are responsible for supporting projects with a high to moderate level of guidance depending on project complexity.
The Associate Sustaining Engineer is expected to learn and understand the primary principles of Design Control methods, medical device regulations, and project management. They will be expected to successfully support and carry out project deliverables/sustaining engineering functions with a focus on quality, complicance, and customer satisfaction.
In addition, this position is responsible for the creation, execution and development of medical device documentation used to create, maintain and make changes to data in ERP (Enterprise Resource Planning) software such as bill of materials, routers, and material masters.
The scope of products for which the Associate Sustaining Engineer will be responsible for 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.

Principal Responsibilities

• Support or lead Sustaining projects and project activities. Level of manager involvement and support will depend on knowledge, experience and tasks.
• Draft and route project initiation documents, identifying the required deliverables per local and global procedures, as well as governing regulations.
• 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 basic project management principles such as scope definition, timeline development, contingency planning and risk planning.
• Assist with quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, with guidance.
• 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.
• Investigate and identify design control requirements.
• Identify needs for design control or sustaining projects based on product, process and business changes.
• Support the tracking and management of sustainingprojects in queue, assisting in identifying potential customer, regulatory, and business impact to establish priority.

Principal Responsibilities Continued

• Understand basic 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 as needed with manager involvement/support dependent on knowledge, experience and tasks.
• 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.
• Creates and modifies manufacturing documentation such as BOM's (Bill of Materials), routers, drawings and procedures.
• Creates and reviews newly created documentation to ensure accurate information transfer to the manufacturing floor for 3 sites.
• Revises drawings, procedures, and forms to capture required changes.
• Assists in the creation of documentation required to meet manufacturing and design control requirements.
• Initiates and leads new product line extensions as it relates to the addition of currently developed and approved products.
• Creates and manages product codes, part numbers, BOM's, routers, material masters and etc. in the ERP and document control systems.
• 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.

Education / Experience Requirements

• Bachelor of Science in Engineering or related technical discipline.
• 0-3 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 excellent 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 with routine supervision.
• 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.

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