Senior Project Engineer
Teleflex

Expected Travel: Up to 10%

Requisition ID: 6235

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

Drive the successful completion of New Product Development (NPD) tasks and projects. Working knowledge of all aspects of product development and design control can begin to mentor others in the process. Work with project management team members to plan, prioritize and sequence tasks that support larger project goals. Has a good network of contacts in other departments and facilities. A good understanding of Teleflex Vascular products.

Principal Responsibilities

• Create design history file documents (DHF), e.g. Design and Development (D&D) plans, user needs documents (Voice of the Customer), design verification or design validation plans, Design Validation protocols, and reports.
• Approve design verification reports and protocols.
• Identify essential design outputs and implement appropriate controls.
• Use Design for Manufacturability concepts in the design of a medical device or process.
• Use Human Factors / Usability Engineering to influence the design of a medical device.
• Lead a Phase review meeting or act as an independent reviewer for a phase review meeting.
• Contribute to the creation of a full development project schedule.
• Present technical concepts to the executive management team.
• Contribute to due diligence and evaluation of acquisition opportunities.
• Contribute to the completion of CAPA projects.
• Provide input to the continuous improvement of the design control procedure.
• Provide support in an audit back room, interfacing indirectly with the auditor.
• Understand and apply horizontal industry standards (e.g. 21 CFR, MDR, ISO 13485/9001, ...)
• Contribute to an FDA submission or contribute to responses to FDA questions surrounding a submission.
• Create test methods to verify requirements aligned to how the device is used clinically.
• Use theory, formula, or engineering principles to guide device design or test methods.
• Use solid modeling, and CAD software to create rapid prototypes.
• Implement root cause analysis tools to discover and solve engineering issues.
• Understand and adhere to the Teleflex code of ethics.

Education / Experience Requirements

• Bachelor of Science in a technical Field, engineering or biomedical preferred.
• 3-5 years in medical device development or 5-10 years in a technical field.

Specialized Skills / Other Requirements

• Mentor others in good communication skills, sense of urgency, dependability, and willingness to take on more responsibility.
• Represent Teleflex R&D at conferences.
• Proficient in the use of SAP to obtain inventory position information or to estimate component or finished good costs.
• Proficient in Agile, ECO, and ECR creation and approval.

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.