R&D Engineer III - Sustaining Projects

Date: May 8, 2022

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 5780

 

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 R&D Engineer III – Sustaining Projects has design responsibility for products that are currently being marketed. This role includes:
•    Spearheading and executing modifications and changes to products currently being marketed to improve and optimize performance. 
•    Investigating product design and reliability issues in partnership with other R&D Engineers, Manufacturing Engineers, Quality Engineers, and other cross-functional departments to determine root cause and implement solutions. 
•    Leading or assisting in efforts to grow manufacturing / supply chain capacity for products currently being marketed.  
This role requires expertise in mechanical design and analysis and product reliability and experience with design and development and design for manufacturability. This role requires a variety of technical skills including failure analysis, testing, prototyping, statistical analyses, component design, and knowledge of plastic and metal component fabrication techniques. Additional skills required include the ability to lead a cross-functional team to identify and drive opportunities or to investigate and resolve issues in a timely manner. 

Principal Responsibilities

•    Maintain product design integrity of products that are currently being marketed using sound engineering skills while following appropriate Design Control requirements.
•    Spearhead and execute modifications and changes to products currently being marketed to improve and optimize performance. 
•    Lead investigations into product design and reliability issues in partnership with other R&D Engineers, Manufacturing Engineers, Quality Engineers, and other cross-functional departments to determine root cause and implement solutions. 
•    Lead or assist in efforts to grow manufacturing / supply chain capacity for products currently being marketed.  
•    Develop engineering solutions to address opportunities for optimizing design or to address observed design issues. 
•    Conduct testing to verify root-cause of failure.
•    Lead prototyping activities of proposed designs to test and evaluate design solutions.
•    Lead verification & validation activities of design revisions.
•    Change component design as required to prevent a recurrence of product reliability defects. 
•    Ensure Design Control procedures are followed and all Design Control documentation is maintained and updated as required by SOP-10270.
•    Review Engineering Change Orders (ECO’s) of post-market products to ensure design reliability, the product meets customer requirements, and to ensure Design Control documentation is complete and correct.
•    Maintain product related design control documentation.
•    Maintain detailed and accurate technical records in an engineering notebook per company policies.
•    Prepare and manage test protocols and reports.
•    Partner with suppliers to correct component deficiencies.
•    Stay current with technology, practices, and general engineering knowledge related to Product Design via seminars, literature, and peer groups.
•    Lead supplier capacity projects to implement multi-cavity tooling, automation, and secondary sourcing of components in collaboration with Manufacturing Engineers, Quality Engineers, and Supply Chain.
•    Change component design as required to increase throughput.
•    Troubleshoots production issues, coordinates and implements improvements and corrective actions. Includes the development or improvement of manufacturing operation sequence and tooling designs.
•    Participate in the NCMR and CAPA processes as the Design owner.
•    Perform other duties as assigned by supervisor.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

•    Bachelor’s Degree in mechanical engineering or equivalent practical experience.
•    Master’s Degree preferred.
•    Minimum of 5 years of related experience; a Master’s degree with 3 years of experience; a PhD without experience; or equivalent work experience. Exceptional mechanical design and analysis skills.

Specialized Skills / Other Requirements

•    Proficiency in SolidWorks.
•    Exposure to all phases of product development including design, implementation, verification, validation, and manufacturing. 
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, MDD, and FDA QSR.

 

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