Project Engineer

Position Summary

The Project Engineering position will provide all aspects of Product Sustainability from Design Control requirements to root cause analysis, and maintenance of the design until transfer to Sustaining Engineering. The candidate is a facilitator; is dynamic, driven, organized and detail oriented; excels in project management; communicates with ease at all levels; thrives in an ambiguous environment and is adept at facilitating actions and resolving conflicts. Understands and is knowledgeable in key aspects of project management, design control, supply chain, manufacturing, and inspection requirements as these relate to Product Sustainability.

Principal Responsibilities

1.    As an integral part of the project team, provides design, manufacturing, supply, timing, and assembly expertise to projects. 
2.    Provide support to project management for sample/product acquisition required for aging, packaging, ship test, sterilization, customer labs, samples, other.
3.    Managing operations-related communications, upward and downward through the organization; escalating key issues and presenting options for resolution to the Senior Leadership Team.
4.    Responsible for managing validation schedules including IQ/OQ/PQ, product production within agreed upon scope, budget, timeline, and quality. 
5.    Working with project management, ensure all components/documents are properly placed into SAP and Agile.
6.    Generate test protocols, analyze test data, and generate written reports.
7.    Contribute to design documentation including input for the Design History File (DHF) and technical design reviews.
8.    For in house manufactured and purchased components, plan and lead the verification and validation activities for new/replacement components.
9.    Individually deliver or guide technical resources in the development/improvement of products and processes, optimize by utilizing tools such as Design Of Experiment (DOE), accomplish their evaluation through verification and validation, and assist in their implementation with appropriate controls and metrics.
10.    Meet project objectives, milestones, and target dates. Update and review project progress on an as-required basis by supervisor.
11.    Direct the efforts of draftsmen, technicians, tradesmen, and lab personnel in the development of test fixtures, equipment, test procedures and documentation.
12.    Lead and participate in design and technical phase reviews.
13.    Ensure projects are developed and documented in compliance with the Teleflex Quality System.
14.    Adhere to and ensure the compliance of Teleflex's Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Prefer Bachelor level degree in Engineering / Technology or equivalent experience in medical device operation, planning and new product introduction
•    At least 2 years minimum engineering experience within a medical device environment
•    Experience working with manufacturing suppliers preferred
•    Excellent communication, presentation, and multi-functional departmental leadership
•    A comprehensive understanding of ISO, GMP and FDA regulations
•    Experience in the commercialization of medical devices in U.S., globally is preferred
•    Experience in Project Management preferred
 

Specialized Skills / Other Requirements

1.    Orientation for detailed work with emphasis on accuracy and completeness
2.    Effective written and oral communication skills
3.    Good organizational and planning skills; drives for results
4.    Effective analytical/problem solving skills
5.    Good interpersonal skills that include working well in a team environment and the ability to lead others.
6.    Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
7.    Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
8.    Working knowledge of international requirements and quality systems.
9.    Computer Literate: Microsoft Office – PC, Word, Excel, PowerPoint
10.    Willingness to travel out of country as required.
 

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