Product Development Engineer

Date: Jun 8, 2021

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4089

 

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 leading and supporting the execution and oversight of Product Development projects within the OEM Performance Fibers (sutures) business unit. With a focus on new development projects such as sterile and non-sterile line extensions, new suture constructs, processes and technologies, they are responsible for leading and supporting Product Development projects with a moderate level of guidance. Leads projects of low to moderate complexity with minimal to moderate guidance. 

The Product Development Engineer is expected to have a moderate level of proficiency in Design Control methods, medical device regulations, and project management. They will be expected to successfully carry out and support project deliverables/product development functions with a focus on quality, compliance, and customer satisfaction.

The scope of products for which the Product Development 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.

Principal Responsibilities

  • Support Product Development projects and project activities of low to moderate complexity with moderate to minimal guidance.  
  • Support moderate to highly complex Product Development projects with a moderate to high level of guidance.
  • Develop custom devices, sutures and subassemblies according to customer design, performance, and quality specifications; on time and within project constraints.
  • Draft and route project initiation/closure documents, identifying the required deliverables per local and global procedures, as well as governing regulations, with minimal to moderate guidance based on project complexity.
  • Interface with cross-functional teams to track project deliverables, responsibility, and progress.
  • Coordinate and execute activities supporting Product Development initiatives and continuous improvement efforts such as procedure revisions, drawing reviews, creation of guidance documents, etc.
  • Apply structured project management principles such as scope definition, timeline development, contingency planning, and risk planning, with a moderate level of guidance.  
  • Lead quoting exercises such as component sourcing, identification of project deliverables and risks, and timeline estimation, of low to moderate complexity with minimal guidance.
  • Review and prepare status reports, modify schedules, and project plans of moderate complexity 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.

Principal Responsibilities Continued

•    Support technical needs and inquiries for Sales, Quality, Regulatory, Marketing and other cross functional teams. Serve as technical resource for team or customers for moderately complex aspects of business/product portfolio.
•    Understand design control requirements and identify strategies to achieve project and business goals with moderate guidance. 
•    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, initate and manage sterility and biocompatibility assessments as well as other deisgn control related documents with moderate guidance. 
•    Effectively establish validation and development plans of moderate complexity with a minor level of guidance. 
•    Ensure Teleflex Medical OEM suture products meet customer and quality system requirements. 
•    Support and lead 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.
•    Assist in establishing continuous improvement initiatives and methods of application.
•    Utilize understanding of medical device devleopment and product line fundamentals to develop project strategies of moderate complexity. 
•    Ensure projects are developed and documented compliant with the Quality System.
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans.
•    Lead and support design control reviews with minimal guidance.
•    Support and/or lead EPIC Medtech customer visits and activities as needed.
•    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
•    Employ an entrepenurial spirit and mindset to support growth of the team and business. 
•    Other responsibilities as required. 
 

Education / Experience Requirements

  • Bachelor of Science in an Engineering or related technical discipline.
  • Minimum 2 years of experience in medical device or related field (3+ years preferred).
  • Minimum of 2 years of experience successfully leading projects and/or project deliverables (3+ years preferred).
  • Good understanding of U.S. FDA GMP and ISO requirements for the design, validation, and manufacturing of medical components and/or devices.
  • Experience with customer facing interaction is highly preferred.
  • CAPM or PMP certification is preferred.

Specialized Skills / Other Requirements

  • Strong interpersonal skills that include working well in a team environment with the ability to effectively manage multiple complex tasks and team activity.
  • Effective written and oral communication skills.
  • Experience developing and tracking timelines effectively.
  • Ability to communicate technical information in a technical and non-technical manner.
  • Demonstrates good judgment when establishing solutions to challenges and business needs of moderate complexity. 
  • 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 or varying complexity and to prioritize/schedule work to meet project needs with routine supervision.
  • Experience with Microsoft Office – PC, Word, Excel, PowerPoint, Project (or similar).

 

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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