Test Engineering Manager

Position Summary

The Test Engineering Manager manages the facility’s Lab and Calibration Technicians and executes the role of test engineer for the facility’s laboratories. This position is responsible for the Product Evaluation Laboratory facility and manages the lab technicians in their activities related to testing of devices required for product development, lab equipment calibration, and preventive maintenance. This individual establishes the laboratory methods, goals, and testing schedules while coordinating laboratory administration including identification and purchase of laboratory equipment, calibration services, and supplies.

Additionally, this position performs the activities of a Test Engineer.  Key activities include assisting in development, design, validation, optimization and maintenance of test equipment and its associated methods and work instructions. The candidate will also assist engineers to define, document, analyze, perform, and interpret product testing.

Principal Responsibilities

•    Ensures the timely, thorough, and accurate completion of all engineering services projects. Ensures documentation packages are complete. 
•    Coordinates the assignment and execution of the controlled laboratory testing, analysis, validations, and documentation including management of data in various electronic records systems (Agile, databases, websites, etc.).
•    Manages the review/approval of electronic test requests and ensures the required equipment, supplies and personnel are available to complete the request within the desired period.
•    Oversees all lab technicians’ activities involved with testing of products and lab equipment calibration services. 
•    Manages laboratory space dedicated to product design and prototype manufacturing equipment activities.
•    Partners with R&D engineering to assist in defining, developing, and validating new and modified test methods (TMV’s).
•    Utilizes software to convert 3D scan files from CT scanner to solid CAD models.  Analyzes and compares models for dimensional differences and conformance to current dimensional specifications.
•    Generates protocols, reports, test procedures, and work instructions for new equipment operation.
•    Develops and implements new test fixtures and equipment for the lab.
•    Drives continuous improvement of processes and systems used within the lab to advance technology, improve efficiencies, impart consistency, and enhance testing capabilities. Shares best practices with other R&D teams and laboratories across Teleflex. 
•    Ensures lab staff is trained to all current procedures and regulatory requirements required for successful performance of their positions.
•    Coordinates, reviews, and performs the preventive maintenance programs for all applicable equipment in the product evaluation laboratory.
•    Supervises the calibration program activities and calibration technicians for all testing equipment in the Morrisville NC site.
•    Prepares the reporting on laboratory and support personnel department metrics and objectives and formally reviews them with management and staff.
•    Maintains GMP/GLP (Good Manufacturing/Lab Practices).
•    Provides laboratory information for audits applicable to the laboratory or products being evaluated there.
•    Demonstrates professional Teleflex culture by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
•    Maintains compliance with principles of accepted employee conduct as specified in departmental policies and procedures.
•    Adheres to and ensures compliance with Teleflex’s Code of Ethics and all company policies and procedures.
•    Performs other related duties as assigned or requested.

Education / Experience Requirements

•    Experience with direct management or mentoring of technical personnel. 
•    Possession of BS degree in engineering or science field, or equivalent preferred.
•    Experience in SAP/Agile systems preferred.

Specialized Skills / Other Requirements

•    Minimum 2 years of experience in product or process development and testing 
•    Proficient in Word and Excel
•    Basic Solidworks capabilities preferred (3D part/assembly modelling and 2D drawings)
•    Basic statistics, Minitab/Matlab
•    Basic electromechanical aptitude
•    Collaboration skills to interface with SME’s, vendors and other BU’s
•    Understanding of ISO and ASTM testing methods for medical devices
•    Understanding of the Design Control Process
•    Effective communicator possessing strong analytical/problem solving skills, background in engineering principles and objective thinking, and an awareness of medical device products and medical device regulations.
•    Basic lab principles and operation.
•    Use of laboratory test instruments.
•    Device technical soundness and feasibility assessment.
•    Experience with U.S. FDA, GMP, GLP, International Regulations and ISO (International Standard Organization) requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices. ISO and ASTM testing methods for medical devices and general plastic components.
•    Ability to work in the lab environment operating test equipment requiring sitting, standing, hand dexterity and range of motion.
•    Experience with data systems.
•    Experience within healthcare products, medical device or pharmaceutical company preferred. 
•    Advanced proficiency in MS Office Tools and other software programs. 
•    Strong organizational and analytical skills. 
•    Speak and write English fluently.

TRAVEL REQUIRED: 0-5%

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