Program Manager, Design Controls

Date: Feb 12, 2021

Location: Maple Grove, MN, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 3417

 

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 position’s responsibility is for driving success in all aspects of the design control and balloons business unit within the OEM division. This role is responsible for driving new business through internal capability improvements and external business development and leading the strategic planning and subsequent execution of the business unit’s objectives. The goal is to make Teleflex a recognized market leader and expert in supplying full design control products, including catheters, balloons, and balloon catheters. The position relies heavily on managing multiple projects, direct reports, schedules, and strategic initiatives while meeting dates and working within a defined budget.

Principal Responsibilities

The Program Manager (Design Controls) is responsible for responding to requests for quotes and customer interactions, managing a team of engineers, technicians, and operators, defining and driving strategic initiatives through market intelligence and interfacing with internal and external development teams, and providing expertise in the design, prototyping, and manufacturing of complex catheters and balloon sub-assemblies.  Candidate must be able to work with minimal supervision in a fast-paced environment and be comfortable in leading and providing mentorship to other engineers. 

The person ideally suited for this role is a complex catheter and delivery system subject matter expert (SME) across multiple areas including design control (21CFR 820), R&D, and process development. This role will also serve as a manager and technical lead across the site to assist in developing the technical skills of other engineers. 

•    Direct the activities of product development engineers and technicians, providing a pathway to develop full contract manufactured products including catheters, balloons, and catheter subassemblies and processes according to customer design, performance, and quality specifications; on time and within budget
•    Manage strategic and financial initiatives and provide project plans on capability improvements and long-term milestones
•    Directs and coordinates activities to develop products and ensure progress as the product specifications/limitations are developed into the technical specification
•    Keeps stakeholders, customers, and others informed of project status and/or related issues
•    Hands-on catheter/balloon design, development, and assembly with customers, both internal and external
•    Subject matter expert in multiple areas including: complex catheters including steerable catheters, smart catheters, complex shape balloons, handle design, molding, braiding, tipping, material science
•    Accurately predict project costs, material lead times, and product delivery schedules during the quoting process
•    Provide leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or manufacturing related
•    Writing, monitoring, managing, and reviewing protocols, including verification and validation tests, ECO, SOP's, BOM's, drawings, and may include calculation and/or FMEA etc...as required to develop, support, or maintain technical documentation
•    Develop products and processes that are reliable as well as identify risks to the project, develop contingency plans, while outlining deliverables and milestones
•    Collaborate to develop quality assurance, testing, regulatory compliance, and quality plans
•    Address customer's issues: improve performance, appearance, and impact on end-user
•    Other duties as assigned
 

Education / Experience Requirements

•    Bachelor's degree in Engineering with a focus in Plastics, Chemical, Biomedical or Mechanical Engineering preferred. Graduate degree preferred.
•    Proven design control experience with multiple products launched through FDA/CE
•    Proven subject matter expert in multiple complex catheter and balloon areas  
•    15+ years experience in Medical Device manufacturing
 

Specialized Skills / Other Requirements

•    Deep understanding of the medical device product development pathway and a drive to execute on strategic business objectives
•    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
•    Expertise in CAD software (SolidWorks, AutoCAD, etc.)
•    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
 

 

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: Minneapolis