Manufacturing Engineer III

Teleflex - Chelmsford, MA

Full-time

Chelmsford, MA

Miscellaneous Manufacturing

About the position

The Manufacturing Engineer III at Teleflex Incorporated plays a crucial role in supporting manufacturing and quality compliance efforts across the business. This position is integral to the Interventional business unit, which focuses on innovative medical devices for diagnosing and treating vascular diseases. The engineer will provide day-to-day support for catheter manufacturing operations, ensuring that production metrics such as yield and efficiency are met and sustained. This role involves driving investigations related to non-conforming products and managing general Non-Conformance (NC) tasks. The Manufacturing Engineer III will also lead continuous improvement projects aimed at reducing costs while maintaining quality compliance, utilizing lean problem-solving tools and methodologies. In addition to supporting manufacturing operations, the Manufacturing Engineer III is responsible for creating and updating essential manufacturing and engineering documentation, including Work Instructions, SOPs, Specifications, and Engineering Drawings. The engineer will also be involved in process qualification and validation activities, which include authoring and executing validation plans and engineering studies in accordance with ISO, FDA, and corporate guidelines. This position requires strong project management skills, including defining project scope, identifying measurable results, and managing timelines effectively. The Manufacturing Engineer III will coordinate with production management to implement necessary technical changes to sustain production line capacity and provide technical leadership and mentoring to Manufacturing Technicians. This role is vital for ensuring that new product platforms are capable of being manufactured efficiently and cost-effectively, thereby contributing to the overall success of Teleflex's mission to improve health and quality of life through innovative medical technologies.

Responsibilities

• Ensure production-specific metrics, such as yield and efficiency, are met and sustained.
• Lead investigations tied to Non-Conformances, Complaints, and CAPA, serving as a team member or leader as required.
• Lead engineering actions identified through production visual management boards.
• Source, plan, present, and deliver significant projects targeted at reducing waste and increasing productivity.
• Demonstrate competency in the use of Six Sigma and Lean Tools associated with the Teleflex Production System (TPS).
• Create and update manufacturing and engineering documentation, and perform training as necessary.
• Demonstrated competence in process qualification and validation activities, including IQ, OQ, PQ, and TMV.
• Support R&D activities by providing technical input and managing the transfer process from design to manufacturing.
• Demonstrate project management skills, including defining scope and managing timelines.
• Coordinate with production management to implement necessary technical changes for production line capacity.
• Provide technical leadership, mentoring, and supervision of Manufacturing Technicians.
• Perform additional duties as requested to support the organization's needs.

Requirements

• Minimum of a Bachelor's degree in Engineering, preferably Mechanical Engineering.
• Minimum of 5 years' experience supporting manufacturing, preferably in medical devices.
• Experience with FDA QSR process and validation documentation requirements is a plus.
• Experience with IQ/OQ/PQ and P/DFMEA is required.
• Project management experience demonstrating the ability to meet schedule and budget targets.
• Experience in the development of production test fixtures is desirable.
• Proficient in most common PC-based applications (Word, Excel, etc.).
• Knowledge of Agile and SAP is a plus.
• Knowledge of six-sigma and Lean manufacturing is a plus.
• Excellent communication, organization, and interpersonal skills.
• Ability to complete tasks and projects with minimal direction.
• Ability to provide work direction/mentor Technicians and other Engineers.
• Ability to effectively communicate with a wide variety of internal and external customers and/or suppliers.
• Knowledge of pneumatics and injection molding is a plus.

Nice-to-haves

• Experience in the development of production test fixtures is desirable.
• Knowledge of Agile and SAP is a plus.
• Knowledge of six-sigma and Lean manufacturing is a plus.