Sustaining Engineer Iii Jobs

Expected Travel: Up to 10%
Requisition ID: 8298
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 400,000 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.

• Management estimate based on product sales and average units per procedure
• McVary, J Sex Med 2014
• No instances of new, sustained erectile or ejaculatory dysfunction in the FDA pivotal study.
• Roehrborn, J Urology 2013 LIFT Study

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
As part of the Interventional Business Unit’s Research & Development Team, the Sustaining Engineer III role provides engineering support to design and/or process alterations to existing products.
Principal Responsibilities

• Develop new test methods and/or alter existing test methods
• Support risk management activities and risk management reviews on existing products.
• Develop design inputs and design outputs for changes to existing product or new distributed product.
• Support engineering activity required to support products through the commercialized life cycle
• Ensure company policies and procedures are followed taking timely corrective action with the help of HR when necessary
• Complete process validation for processes and products including IQ, OQ, PQ & PPQ.
• Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation.
• Coordinate Design Change and Process Change activities for the impact to the organization; create evidence based project proposals in alignment with quality system requirements
• Support regulatory approvals and responses to regulatory questions for existing products.
• Maintain and supplement design history files that are thorough and accurate for existing product
• Provide R&D support for verification, qualification, and validation studies on existing products.
• Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.

Education / Experience Requirements

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering or related discipline, or related practical experience
• Medical device experience a plus.
• 5+ years related experience working in a new product development, sustaining engineering, quality engineering or design assurance role.
• Experience with ISO13485, MDD, FDA Quality System Regulations is preferred

Specialized Skills / Other Requirements
SPECIALIZED SKILLS & OTHER REQUIREMENTS: Additional preferred or required qualifications.

• Proven communication skills with cross-functional interaction
• Experience with quality management systems and medical device regulations
• Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, stamping, adhesive and thermal bonding and various other processes for medical device fabrication and design is preferred
• Self-motivated individual with proven ability to work independently from objectives
• Proven problem solving and trouble shooting skills
• Knowledge of clinical applications and associated product requirements with the ability to translate these requirements into detailed specifications.

TRAVEL REQUIRED: Up to 10%
The pay range for this position at commencement of employment is expected to be between $100,000 - $115,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.