Product Complaints Engineer

Date: Apr 22, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: None

Requisition ID: 3313

 

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

The Product Complaints Engineer investigates customer complaints, facilitates investigations, generates complaint investigation reports, and ensures completeness and consistency of the complaint files and records documentation. As an integral member of the Quality team, this position is responsible for creating investigation methodologies, instructions, fixtures, tools and equipment to facilitate the complaint investigation process. This position requires experience with FDA Quality System Regulations and the ability to perform at high levels in a high-paced, dynamic environment.

Principal Responsibilities

•    Conduct and record timely investigation of returned products through troubleshooting and testing to determine root cause of reported failure mode.
•    Partner with Quality Engineering, Manufacturing Engineering, and Product Development to analyze test results to demonstrate root cause failures and linkage to customer reported symptoms.
•    Escalate complaints when encountering new failure modes and partner with Engineering, Field Personnel, and Quality Assurance to investigate.
•    Collaborate with Clinical and Medical Affairs on hazards evaluation and potential patient risk and safety hazard investigations.
•    Perform Device History Review (DHR) and record results when necessary.
•    Summarize investigation and analysis results in a Product Analysis Summary Report and submit for appropriate approvals.
•    Communicate potential trends associated with product complaint data to management.
•    Maintain sufficient and accurate technical records per company policy.
•    Participate in training and development of Laboratory personnel.
•    Ensure work performed complies with FDA's Quality System Regulatory, ISO 13485, MDD, PAL and all other applicable quality requirements.
•    Perform other Quality System duties (e.g., CAPA, Internal Audits), as assigned.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high achieving, and fun!

Education / Experience Requirements

•    Bachelor’s degree in Science, Engineering, or another technical field; or equivalent practical experience.
•    At least 4 years of relevant experience with medical device investigations and complaints, or equivalent experience in a related field.
•    Experience with ISO13485, MDD, and FDA Quality System Regulations is preferred.
•    Experience handling biohazards materials preferred.
•    Experience with Pilgrim SmartSolve software a plus.
 

Specialized Skills / Other Requirements

•    Strong interpersonal skills with the ability to work collaboratively with others in a team environment
•    Strong technical writing, analytical, critical-thinking, Proficient problem solving, and interpersonal communication skills.
•    Knowledge of reliability statistics, FMEA processes, Fundamental knowledge of manufacturing processes, and medical device risk management standards.
•    Proficient in Microsoft Word, Excel, and Outlook.

 

 

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: San Francisco
Nearest Secondary Market: Oakland