Project Engineer

Date: Feb 5, 2021

Location: Wyomissing, PA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3367

 

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.

 

Vascular Access – Built on a history of innovation, our Arrow® brand of technically advanced vascular access devices are renowned throughout the world. Many of our vascular access products have antimicrobial and antithrombogenic protection designed to reduce vascular-related complications and include long and short dwell central venous catheters (CVC), sheath introducers, arterial lines, peripherally inserted central catheters (PICC), as well as specialty devices and an advanced vascular positioning system to facilitate precise placement of a PICC or CVC near the heart. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

Individually lead the delivery of projects to maintain business continuity in areas such as 1) complying with regulations; 2) resolving product performance issues; 3) sustaining supply chain continuity; and 4) improving margins.

Work-related to products and components may include efforts in all technical phases of product and process development, including design and development planning, requirements definition, product development, root cause analysis, verification/validation and manufacturing aspects using Arrow's design control policy and procedures. Aid in product improvement and cost reduction, facilitate change management and documentation, develop, troubleshoot and maintain manufacturing processes, equipment and systems., Work with component suppliers to develop new components and/or improve existing ones.
 

Principal Responsibilities

•    Directly lead engineering efforts to develop components, specifications and processes with input from technical experts, physicians, marketing and manufacturing adhering to the design control process. Lead projects in the redesign or replacement of existing components/assemblies and processes to improve quality, utilize automated production techniques, optimize process capabilities, and produce better products in a more cost-effective manner. Interface with suppliers, Strategic Sourcing, R&D, Quality and Regulatory Affairs to deliver projects.

1. For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement and existing products and components.

2. Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as DOE, accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.

3. For in house components, train manufacturing management, operator and set-up personnel to manufacture according to specifications.

4. For both in house and purchased components, lead the transfer of parts, assemblies, documentation and processes from prototype stage, through pilot to production. Define specifications for the generation of products/processes including experimental activity specifications through production lifecycle for the Device Master Record as required.

5. Manage supplier initiated changes as required to sustain supply chain following applicable standard operation procedures.

6. Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.

7. Interface with suppliers to obtain quotations, purchase components, and debug problems with production parts.

8. Interface with purchasing and marketing to develop supplier agreements for components and/or new products.

9. Deliver or lead the resolution of manufacturing issues and conduct improvements of manufacturing processes through the use of statistical data analysis techniques such as Process Capability Studies, DOE and SPC. Provide uniform solutions for international manufacturing operations.

10. As requested, work with the Product Performance Team and R&D personnel to lead investigation of product complaints to determine root cause and implement corrective action.

11. Mentor others in learning the requirements of and operate in a medical device manufacturing environment.

12. Mentor others in learning the best practices and develop skills in project management and technical writing.

13. Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of products, processes, test fixtures, equipment, test procedures and documentation.

14. Lead and participate in design and technical phase reviews.

15. Interview, recommend and assist in selection of department personnel including engineers and summer interns.

16. Support regulatory submissions and clinical trials as required.

17. Ensure projects are developed and documented compliant with the Quality System.

19. Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Bachelor of Science or Professional Engineer Certification -Engineering or technical discipline
•    1-2 years previous experience in related field (e.g. medical device manufacturing and assembly, disposables manufacturing processes, plastics, automation)
 

Specialized Skills / Other Requirements

 

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.


Nearest Major Market: Reading PA