Principal R&D Engineer

Date: Sep 19, 2022

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 7058

 

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.

 

OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

This positions responsibility is for managing and developing new products, while interfacing with customers, vendors, and internal departments in order to achieve the desired product specification. The goal is to lead and/or direct higher level engineering efforts to develop products, define specifications, to establish reasonable timelines while developing high quality products that meet the end user’s expectations. Relies heavily on meeting dates, accountability while using experience and judgment to develop products and meet goals with minimal supervision.

Principal Responsibilities

•    The Principal R&D Engineer is a site technical expert for catheter and device devleopment. They are responsible to coach, develop, manage and motivate staff to ensure that employees achieve their full potential. In conjunction with the Engineering Manager, develop and cascade departmental long term and short term business objectives, in line with business needs. They will assist in responding to Requests for Quotes, managing quick turn medical device OEM projects, and prototyping complex catheters sub-assemblies. Candidate must be able to work with minimal supervision in a fast-paced, customer-centric environment; should enjoy communicating with customers, vendors, and internal departments; and be passionate about our goal of consistent on-time delivery of high quality products. 

ADDITIONAL RESPONSIBILITIES WILL INCLUDE, BUT ARE NOT LIMITED TO: 
•    In depth knowledge of hands-on catheter/balloon design, development, and assembly 
•    Lead by example in ensuring that all elements of projects and process improvements are delivered to a high standard within the Engineering team – this includes documentation, reviews, testing, change-review, training, line support, etc.  
•    Accurately predict project costs, material lead times, and product delivery schedules during the quoting process.
•    Develop bills of materials and assembly method, and provide any needed training to technicians and assemblers.
•    Will work with many areas including: complex catheters including steerable catheters, smart catheters, complex shape balloons, handle design, molding, braiding, tipping. 
•    Oversee development of complex catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget.
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Review and prepare status reports, modify schedules, and project plans as required
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
•    Apply design controls from initial customer requests throughout the products life cycle
•    Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECOs, SOP's, BOM's, drawings, FMEA and other technical documentation
•    Intimately oversee development of protocols, including verification and validation testing, drawings, calculation and/or FMEA etc...to develop and support technical documentation
•    Take total ownership for area of responsibility. This can be interpreted as taking a proactive approach to improvement and anticipating, recognizing, and dealing with problems before they become major issues. 
•    Lead Product development, new process development or process improvement projects achieving the required standard in cost management, quality assurance, health and safety assurance, productivity and sales growth.
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
•    Address customer's issues: improve performance, appearance, and impact on end-user
 

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
•    Graduate degree in Plastics, Chemical, Biomedical or Mechanical Engineering highly preferred
•    Proven catheter development experience 
•    12+ years' experience in Medical Device development or manufacturing
 

Specialized Skills / Other Requirements

•    Working knowledge of manufacturing processes related to medical device manufacturing
•    Ability to prioritize and work independently as a self-starter with strong proactive work ethics
•    Experience with design controls, FDA regulation, GMP practices, and QSR requirements
•    Proficient in Microsoft Office and Microsoft Project
•    Experience with Risk Analyst tools and procedures
•    Proven track record in Leadership role and utilizing Project Management
•    Proven track record in product development, design, and working closely with manufacturing
•    Demonstrated customer relations, problem solving, and product development skills
•    Ability to influence across boundaries, drive collaboration, and develop product to meet the end users expectations
•    Must be well-organized, detail-oriented, with excellent oral and written communication skills
#LI-LM1

 

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.

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