Principal R&D Engineer

Date: Jan 9, 2023

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7533

 

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. 

 * 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

Principal Research & Development Engineer for Teleflex Interventional Urology is in Pleasanton, CA. Develops innovative products that address important unmet needs for urological conditions. As an integral member of the R&D team, this position is primarily responsible for developing innovative new products and making significant improvements to existing products. Primary responsibilities include user needs assessment, ideation, rapid prototyping, concept down selecting, design and process development, characterization, testing and statistical analysis are keys to this position. 

Individuals in this role must be skilled as mechanical design engineers experienced with implants, polymers, metals including Nitinol, stamping, extrusion, molding, machined parts, bonding and other commonly practiced manufacturing methods.  Critical thinking, advanced six sigma design capabilities, design for manufacturing/reliability, knowledge of high-volume production methods, the ability to work in a fast-paced environment, apply advanced technical principles, theories, and concepts in working on complex technical problems with strong communication skills are also keys to success in this role.  The individual will be working with and mentoring a motivated team of engineers as well as making a big impact on the overall business by developing innovative new products and making significant improvements in existing products.
 

Principal Responsibilities

•    Develop new products and product concepts using existing and emerging technologies per Design Control requirements.
•    Mentor, guide, supervise, train, and assist R&D engineers and Laboratory personnel in their work. Assigns tasks to and directs engineers, technicians, and administrative staff.
•    Manage projects, including scheduling, budgeting and documentation.
•    Serve as the technical specialist for the organization in the application of advanced concepts, principles, and methods in an assigned area.
•    Define customer requirements and engineering specifications.
•    Ideation, concept generation and patent disclosure submissions.
•    Design prototypes and feasibility models for proof of concept testing.
•    Develop new test methods as needed.
•    Analytically assess data and test methods to evaluate designs and down select.
•    Peer review drawings and provide input to ensure engineering rigor.
•    Work closely with suppliers to ensure component delivery and assembly operators to ensure manufacturability of new design.
•    Lead overall design efforts including design/process characterization, verification and validation of new product designs. 
•    Prepare, participate in and lead Design Control documentation activities, Design Reviews, Quality Audits and CAPAs.
•    Direct and monitor outside research and development projects. 
•    Through seminars, literature and peer groups, stay current with technology, practices and general engineering knowledge related to one’s field.
•    Keep informed of new developments and requirements affecting the organization for the purpose of recommending changes in programs or applications. 
•    Perform other duties as assigned by supervisor.
•    Contribute to our culture that thrives on shared values, with people at the center of all we do. Working together, our shared values of Entrepreneurial Spirit, Building Trust, and Make It Fun allow us to produce outstanding products and services that genuinely make a difference to people's lives around the world.
 

Education / Experience Requirements

•    Typically requires a minimum of 12 years of related experience with a Bachelor’s degree in Mechanical Engineering; or 10 years and a Master’s degree; or a PhD with 7 years of experience 
•    Design experience using injection molding, stamping, metal injection molding, springs, and related fabrication processes.

 

Specialized Skills / Other Requirements

•   Exceptional mechanical design skills on complicated mechanisms and systems.
•    Expertise in SolidWorks.
•    Mastery of all phases of product development including design verification, validation, implementation and manufacturing. 
•    Demonstrated history of products successfully reaching the marketplace.
•    Exceptional verbal and written communication skills.
•    Familiarity with ISO 13485, MDR, and FDA QSR.
•    Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which Interventional Urology complies.
•    Ability to travel approximately 10% of the time in the US and internationally as needed.  

 

WAGE RANGE/RATE: $160,000 - $185,000, based on experience and qualifications.

 

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