Project Engineer

Position Summary

Lead and coordinate the technical activities related to the development, implementation, and sustaining of Arrow Select Kits (ASK) and other custom procedural kit configurations. Ensure timely execution of projects through collaboration with cross-functional teams, adherence to design control and quality system processes, and effective communication with internal and external stakeholders to ensure continued customer continuity for product services. Adhere to and ensure compliance with Teleflex’s Code of Ethics, all company policies, procedures, and quality standards.

Principal Responsibilities

ASK Kit Development
•    Lead engineering activities supporting ASK custom kit development including component feasibility evaluation, prototyping design configurations, and documentation through all phases of Teleflex quality system design control.
•    Interface with Marketing, Regulatory, and Customer Support to translate customer and market needs into viable, compliant product configurations. 
•    Collaborate with cross-functional project teams to ensure on-time completion of engineering changes, validations, and production readiness.
•    Execute verification and validation activities related to component changes, process updates, and kit configuration modifications in accordance with design control requirements.
•    Support the creation, review, and approval of documentation within the ECO/ECR process, including drawings, specifications, and manufacturing instructions.
     
Sustaining
•    Manage sustaining engineering projects post-production lifecycle for existing ASK products, including BOM maintenance, cost reduction, supplier transitions, obsolescence management, and process improvements.
•    Provide technical support to Manufacturing, Quality, and Supply Chain to resolve issues impacting product performance, manufacturability, or supply continuity.
•    Support new component qualifications and/or component obsolescence for portfolio optimization activities
•    Drive continuous improvement initiatives to enhance product quality, process efficiency, and cost-effectiveness.
•    Participate in risk management and design reviews to ensure compliance with internal and external standards.
•    Support product complaint investigations as needed to determine root cause and implement corrective or preventive actions.
•    Mentor and provide guidance to colleagues/peers in ASK processes, design control, and documentation best practices.

Education / Experience Requirements

•    BS in Engineering 
•    3-5 years of work experience in R&D within the medical device industry     

Specialized Skills / Other Requirements

•    Engineering experience within the medical device industry following a robust design control process and regulatory standards.
•    Strong organizational skills with the ability to manage multiple projects in a fast-paced environment.
•    Proficiency in product lifecycle management (PLM) and enterprise resource planning (ERP) systems and change control processes.
•    Effective verbal and written communication skills; able to communicate across technical and non-technical teams.
•    Strong analytical, problem-solving, and documentation skills.
•    Collaborative, team-oriented mindset with demonstrated ability to work cross-functionally.
•    Proficient in Microsoft Office Suite; experience with CAD and ERP systems a plus.

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