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 initial 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 normal sexual function1. The FDA-cleared UroLift System is clinically proven to treat lower urinary tract symptoms due to BPH. 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 100,000 men worldwide have been treated with the UroLift System, which is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. 1 *No instances of new, sustained erectile or ejaculatory dysfunction. McVary; Roehrborn, J Urology 2013 LIFT Study.
As an integral member of the Operations team, the Manufacturing Process Engineer optimizes production processes by improving equipment uptime and efficiency, implementing lean principals and enhancing manufacturing processes. This position works with other engineers in Operations, R&D and Quality to prepare for manufacturing scale up and then execute the plan. This position requires basic understanding of lean principals and implementation of these to realize manufacturing efficiencies and effective communication and analytical skills.
- Analyze data and processes to determine bottlenecks in process or equipment and establish priority projects based on this analysis to gain manufacturing efficiencies
- Understand and implement Lean principles to our manufacturing process and also through the entire chain/flow of material
- Lead projects to prepare for and to execute manufacturing scale up
- Prepare process development protocols and coordinate and execute related activities
- Support equipment installation qualification activities for new equipment including implementing equipment/tooling processes to improve efficiencies, increasing productivity, and/or enhancing quality
- Assist with project execution by writing and processing protocols, testing components, and partnering with Engineers and the Operations team
- Partner with cross-functional team members (Manufacturing Assemblers to Vice Presidents) as well as outside vendors and contractors to accomplish project objectives
- Prioritize and balance workload of multiple project assignments based on business and functional objectives
- Follow and observe all regulatory requirements (GMPs, 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 3 years engineering experience in the medical device field or regulated industry strongly preferred
- 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
- 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.