Product Development Engineer

Date: Feb 9, 2021

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 3400

 

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 Product Development Engineer is responsible for management, execution and oversight of Product Development and sustaining projects within the OEM Performance Fibers business unit. They must be capable of effectively leading projects ranging from minor to high complexity with minimal supervision.  The Product Development Engineer is expected to have a strong knowledge of Design Control methods, medical device regulations and project management principles. They will be expected to successfully carry out projects and deliverables across cross-functional teams and multiple facilities, with a focus on quality, compliance, and customer satisfaction. 
The scope of products for which the Product Development Engineer will be responsible for developing and sustaining includes, sterile and non-sterile suture components, contract manufactured suture products, and sterile suture devices for the Mansfield, MA and Coventry, CT Facilities. 
 

Principal Responsibilities

•    Plan, lead, and execute Product Development and sustaining projects, including those which are highly complex, with minimal supervision and a high level of independence. 
•    Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within project constraints.
•    Interface with cross-functional teams to maintain accountability, coordinate and execute deliverables supporting new product and capability development projects, sustaining projects, and other initiatives. 
•    Apply structured project management principles such as scope definition, timeline development, contingency planning, risk planning and mitigation, stakeholder analysis, et cetera, to plan, lead and execute projects of low to high complexity.
•    Accurately predict project requirements, costs, lead times, and delivery schedules during the quoting and project execution processes.
•    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.
•    Serve as technical resource to sales, Quality, Regulatory, Marketing and Customer Care. 
•    Serve as subject matter expert (SME) in design control and product capabilities to effectively lead and support Performance Fibers projects and initiatives. 
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Provide technical leadership, lead root cause analysis and customer or project-related problem resolution activities; materials, assembly, functional, or manufacturing related.
•    Generating and developing protocols, reports, and studies, including verification and validation testing. Supports engineering and cross-functional teams in protocol and study-related strategy and activities. 
•    Lead and support proper creation and maintenance of drawings, procedures, design documents (DFMEA, FMEA, Traceability Matrix, etc) technical documentation.
•    Ensure projects are developed and documented compliant with the Quality System.
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
•    Lead and participate in design and technical phase reviews.
•    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
•    Serve as central contributor to identification and execution of continuous improvement initiatives.
•    Utilize and integrate lean principles within project, process, and resource management activities, acting as a catalyst for initiating change.
•    Employ an entrepreneurial spirit and mindset to support growth of the team and business. 
•    Empower team members and cross-functional teams to use critical and creative thinking to identify opportunities to act independently and initiate change.
 

Education / Experience Requirements

•    Bachelor of Science in an Engineering or related technical discipline.
•    Minimum of 5 years of experience in medical device or related field. 
•    Minimum of 5 years of experience successfully leading projects and/or project deliverables.
•    Knowledgeable in U.S. FDA GMP and ISO requirements for the design, validation, and manufacturing of medical components and/or devices.
•    Experience with EU MDR regulations and/or compliance projects is highly preferred.
•    PMP certification is preferred.
 

Specialized Skills / Other Requirements

•    Working knowledge of project management principles and methodology.
•    Working knowledge of international regulations, requirements and/or ISO 13485 quality systems.
•    Strong interpersonal skills that include working well in a team environment with the ability to effectively lead and manage others.
•    Effective written and oral communication skills.
•    Focus on detailed work with emphasis on accuracy and completeness.
•    Excellent organizational and planning skills; drives for results.
•    Effective analytical/problem-solving skills.
•    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
•    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
•    Proficient in Microsoft Office – PC, Word, Excel, PowerPoint, Project (or equivalent).
 

 

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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