Product and Process Development Engineer, Sustaining

Position Summary

This position supports the Sustaining Engineering group for the Emergency Medicine product lines. However, assignments may include work for other products within the Teleflex portfolio. These products are generally high-volume disposable medical devices. Incumbent organizes and manages multiple projects and ensures that they are completed in a timely manner. Assignments may focus on sustaining engineering assignments to provide creative solutions or modifications to existing products when problems arise. Performs other duties as required or assigned.

DISTINGUISHING CHARACTERISTICS:
Incumbent in this job-class performs assignments including the planning and coordination, development, and implementation of engineering activities in support of changes and improvements to existing product lines and minor design changes through manufacturing scale-up. Incumbent at this level will receive occasional instruction or assistance as new or unusual situations arise and is required to be fully aware of the operating procedures and policies of the work unit.

Principal Responsibilities

•    Assist with the development and maintenance of Design History File documentation.
•    Create and modify 3D Solid CAD models in SolidWorks of devices and equipment for their projects and in support of the Emergency Medicine Sustaining department’s project work.
•    Prepare and coordinate the execution of protocols for the design verification of changes to existing medical devices and components.
•    Design, build, test, and validate product assembly-stations, test-fixturing, and measurement equipment.
•    Research new or alternative manufacturing methods to determine their feasibility in improving the cost of manufacture of existing products.
•    Gather data on current products to support marketing, engineering, and regulatory requests. 
•    Support multiple projects and ensure their timely completion. 
•    Responsible for formal project management and related project documentation for small to intermediate level design and sustaining projects.
•    Help generate design modification ideas to existing products to improve their design for manufacturability.
•    Understand and update risk documentation to conform to current standards.
•    Serve as a participant in integrated core teams as the Sustaining Engineering representative and/or technical lead. 
•    Collaborate with integrated teams (Engineering, Quality, Regulatory) to understand technical targets and design control requirements.
•    Support sustaining engineering efforts for the manufacturing plants as applicable. Teleflex is a Global organization with manufacturing facilities in the US, Mexico, and the Czech Republic. The ability to travel to international locations is mandatory.
•    Support sustaining engineering efforts for 3rd party suppliers of Teleflex products and purchased finished goods.
•    Demonstrate professional responsibilities by cooperating with personnel to achieve department objectives and maintain good employee relations, departmental goals and objectives, and interdepartmental objectives.

MARGINAL FUNCTIONS
•    Enhances personal growth and development through participation in education programs, current literature research, training meetings and workshops.
•    Participates actively in continuous quality improvement activities while complying with safety standards.
•    Maintains compliance with principles of accepted employee conduct as identified in the Teleflex employee handbook and as specified in departmental policies and procedures.

Education / Experience Requirements

•    Possession of bachelor’s degree in engineering.
•    Experience in SolidWorks CADD (design/drafting) program.
•    Microsoft Office Suite, (Project, Word, and Excel). 
•    Experience in molding, plastic extrusion and plastic part assembly processes and methods preferred.  
•    Experience with U.S. FDA GMP and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices preferred.
•    Working to comply with ISO and ASTM testing methods preferred.
•    Principles and practices of professional engineering.
•    Knowledge of regulations pertaining to medical device design and design modifications preferred.

Specialized Skills / Other Requirements

•    Strong written and verbal communication skills and attention to detail. 
•    Effectively present information and respond to questions from groups of managers, customers, and peers.
•    Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
•    Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
•    Analyze complex, technical, and administrative problems and adopt an effective course of action.
•    Make effective presentations to, and participate in a variety of meetings and conferences with other groups.

Ability To:
•    Demonstrate creativity and ingenuity in applying engineering principles and practices.
•    Draw solutions form a wider range of experience.
•    Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
•    Prepare clear and concise protocols and reports.
•    Establish and maintain cooperative relationships with those contracted in the workplace.
•    Speak and write English fluently.

#LI-NR1