Sr. Design Assurance Engineer
Teleflex

Job Info

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Expected Travel: None

Requisition ID:4418

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.

Interventional Urology - NeoTract is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. As part of the Teleflex Interventional Urology business unit, NeoTract's focus is on improving the standard of care for patients with benign prostatic hyperplasia (BPH) using the UroLift® System, a minimally invasive, permanent implant system that treats symptoms while preserving sexual function*1,2. The UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH in men over the age of 45. The UroLift System lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. More than 175,000 men have been treated with the UroLift System in select markets worldwide.** Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.

*No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.

** Management estimate based on product sales and average units per procedure

1. Roehrborn, J Urology 2013 LIFT Study
2. McVary, J Sex Med 2014

Indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.

Position Summary

• Fulfill design assurance role on new product development (conception to launch) and sustaining projects
• Lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
• Support Regulatory Affairs with creating submissions and responding to submission questions.
• Primary responsibility is New Product Development; secondary responsibility is Sustaining Engineering.
• Continued support and optimization of DA centric New Product Development deliverables and processes, accounting for cross functional system interactions.

Principal Responsibilities

• Participate and lead New Product Development Phase Reviews and Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Create and support the development and validation of new test methods.
• Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Develop the strategy and manage the execution of design verification and validation.
• Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
• Develop, execute, and manage First Article inspections.
• Support regulatory approvals and responses to regulatory questions.
• Support Sustaining Engineering for design and process changes to commercialized product.
• Provide direction to design assurance engineering technicians supporting assigned projects.
• Review and improve Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.

Education / Experience Requirements

• BA/BS in Engineering or physical sciences required.
• Five years of related experience required.

Specialized Skills / Other Requirements

• Ability to work independently and with minimal direction.
• Ability to define, organize, and manage individual and team tasks.
• Provide direction to extended and core team members.
• Effective verbal and written communication.
• Proficient in technical report writing and review.
• Interpersonal skills; working in a team and as an individual contributor.
• Structured and methodical problem-solving approach.
• Strong understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Strong understanding of industry regulations such as ISO13485 and FDA QSR's.

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.

© 2021Teleflex Incorporated. All rights reserved.

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