R&D Manager

Date: Jan 9, 2023

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7534

 

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

Research & Development Manager for Teleflex Interventional Urology is in Pleasanton, CA. Provides management support for the design and development and testing of innovative, new products within the Interventional Urology space. Applies advanced technical principles, theories, and concepts in working on complex technical problems. Provides engineering leadership and management of projects from concept generation through to regulatory approval and commercialization. Provides support and leadership for projects as they move through Product Development Process including supporting customer-facing events with product demos, concept & feedback sessions and physician interviews. Responsible for defining skills and coaching engineers in customer interactions, specifically focusing on voice of customer, need translation, and product requirement generation for the design and development of medical devices and medical device patents. Requires strong leadership and project management skills, and experience in mechanical design and analysis, product reliability, statistical methods and design for manufacturability, including high volume production methods.

Provides design inputs to generate Design, Process, and User FMEAs, risk analysis, Corrective and Preventive Actions (CAPA), design verification and validation, process development and validation, root cause analysis, tolerance analysis, test method validation. Provides support and leadership for team to complete these activities appropriately. Understands industry and government regulations. Uses this understanding to coach engineers on methodologies and support submissions within Interventional Urology. Provides oversight and technical rigor assessments of the design, development and testing of delivery systems and implants, polymers, metals including Nitinol, stamping, extrusion, molding, machined parts, bonding and their performance in the product life cycle. Understands the impact of sterilization, shelf life and other use conditions on the design and materials.
 

Principal Responsibilities

•    Oversee and manage Research and Development efforts toward efficient completion of the Company goals and objectives.
•    Manage and coordinate the planning, scheduling, and budgeting related to all R&D activities.
•    Ensure R&D efforts related to development of new products and design modifications of existing products follow Design Control procedures.
•    Interface with subject matter experts from outside sources, companies, and forums to maintain an understanding of new developments in medicine and engineering.
•    Partner with cross-functional teams and directly with customers to ensure development and testing of prototypes meet market and customer requirements.
•    Provide guidance and ongoing review in the development of final reports for regulatory submissions.
•    Supervise Engineers and projects.
•    Participate in the development of the Company's R&D standards and procedures.
•    Oversee the review of document changes for research and development impact.
•    Ensure compliance of department staff regarding job descriptions and training requirements.
•    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

•    Bachelor's Degree in Mechanical or Biomedical Engineering or related engineering degree.
•    Master's Degree preferred.
•    At least 8 years of medical device engineering experience
•    Past people management experience is required

 

Specialized Skills / Other Requirements

•    Exceptional mechanical design and analysis skills.
•    Proficiency in SolidWorks.
•    Proficiency in all phases of product development including design, implementation, verification, validation, and manufacturing.
•    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. (Ability to manage travel and expenses per approved budget.)
 

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