Manufacturing Engineer III

Date: Nov 16, 2021

Location: Pleasanton, CA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 4914

 

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

Support the development and transfer of new products into production in accordance with established policies, goals and objectives.  Responsible for resolving technical issues to production support, reviewing engineering data and creating manufacturing instructions, fixtures, bill of materials, parts, tools and equipment for manufacturing products to comply with design specifications.

Principal Responsibilities

•    Work closely with R&D through development and production release of new products to manufacturing to meet capacity and cost targets.
•    Develop pilot processes for initial R&D prototypes and feasibility models for proof of concept testing including associated documentation such as BOM’s, component and assembly drawings/specifications, DHR’s, MPI’s, and DMR’s
•    Drive process and product improvement activities to promote product quality, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool/fixture design, design experimentation for process and equipment
•    Partner with cross-functional team to identify, develop and coordinate with suppliers for tooling, processing, components, and assemblies
•    Complete process validation for processes and products including IQ, OQ, PQ & PPQ.
•    Partner with cross-functional teams to facilitate technology transfer of new product introduction and provide recommendations that improve manufacturing processes.
•    Resolve technical issues and provide production support to quickly address production issues and prepare the line for high volume manufacturing and to ensure product supply is not impacted
•    Update manufacturing procedures, specifications etc. as required through ECO process.
•    Prioritize and balance the workload of multiple project assignments based on business and functional objectives 
•    Follow and observe all regulatory requirements (GMP, ISO, FDA, internal policies, etc.) and comply with NeoTract Safety/Environmental Requirements, safe working conditions, and practices.
•    Perform other related tasks as requested.
•    Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!

Education / Experience Requirements

•    Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering or related discipline, or related practical experience
•    Minimum of 5 years engineering experience in the medical device field
•    Prior work experience in a laboratory or manufacturing setting is preferred
•    Experience with ISO13485, MDD, FDA Quality System Regulations is preferred

Specialized Skills / Other Requirements

•    Good documentation skills and the ability to write accurate test procedures/summaries/reports upon completion of requested tests required.
•    Effective verbal and written communication, analytical and interpersonal skills and ability to communicate at all levels across the organization
•    Ability to exhibit sound judgment in the formulation and solution of problems. 
•    Knowledge of basic anatomy and ASTM standards for medical devices is a plus
•    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 NeoTract complies.
•    Experience and knowledge in software tools used to analyze data is a plus (e.g. MatLab, SPC, simulation software, database generation, MiniTab, DOE)

 

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