Teleflex Sr. Product Development Engineer in Morrisville, North Carolina

Position Summary: Under minimal direction, incumbent is responsible for the development and maintenance of Anesthesia products; however assignments may include work for other products within the Teleflex portfolio. Experience and background requirements should focus on Disposable Anesthesia products. Incumbent organizes and manages multiple projects and insures projects are completed in a timely manner; creates design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested; and performs other related duties as required.

Incumbent in this class performs the advance level scope of assignments to plan, design and coordinate the development and implementation of molds and related engineering activities to support new product development projects through manufacturing scale-up. Incumbent at this level receive only occasional instruction or assistance as new or unusual situations arise, and are fully aware of the operating procedures and policies of the work unit.

Principal Responsibilities:

  • Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms.

  • Prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, Market Specifications, etc. according to established Product Development Procedures, and initiates formal reviews to get approved per said procedures.

  • Develops, maintains and publishes product Development Plans for assigned projects with critical milestones and timelines.

  • Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.

  • Supports new product development and sustaining engineering efforts for the Manufacturing plants as applicable. Teleflex is a Global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia and Germany. Ability to travel in international locations in mandatory.

  • Investigates and resolves technical problems involving product performance, production equipment or facility systems affecting production.

  • Coordinates the product design and development process with appropriate support departments such as engineering, regulatory, documentation, tooling and manufacturing.

  • Serves as the project leader for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable.

  • Prepares or follows up on preparation of design drawings, specifications, estimates of costs, mainframe updates, etc.

  • Supports Packaging and Kit generation for assigned products

  • Discusses and consults with sales staff or customer on product requirements and specification where design or manufacturing problems are involved.

  • Works with manufacturing in the justification and the selection of the manufacturing process, and assigns projects and establishes priorities to ensure datelines and goals are achieved.

  • Develops assembly methods and procedures; creates engineering draws and specifications.

  • Coordinates changes in process, tolling and equipment identified to positively impact the manufacturing process, while staying within Design Control guidelines.

  • Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, and capital spending and expense status.

  • Participates actively in continuous quality improvement activities through compliance with safety standards.

  • Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.

MARGINAL FUNCTIONS

  • Enhances growth and development through participation in education programs, current literature, training meetings and workshops.

  • Participates actively in continuous quality improvement activities through compliance with safety standards.

  • Demonstrates professional responsibilities 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 identified in the Teleflex employee handbook and as specified in departmental policies and procedures. Perform other related duties as assigned or requested.