Overview
Expected Travel : None
Requisition ID : 12753
About Teleflex Incorporated Teleflex is a global provider of medical technologies focused on improving health and quality of people’s lives. We offer solutions across anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. Teleflex includes trusted brands such as Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck.
Global Operations is responsible for product fulfilment to all customers from end to end, with a focus on quality, service, and value. We are a dynamic team that supports enterprise excellence in a healthcare context.
Responsibilities
- Proactive involvement in design and technical phase reviews and discussions.
- Actively contribute to process development activities, including designing the process and evaluating / optimizing product design and manufacturing processes through Design for Excellence (DFX). DFX activities include manufacturing (DFM), cost (DFC), assembly (DFA) and testability (DFT).
- Perform stack-up analysis on fitting and assembly to finalize critical points and Essential Design Output (EDO).
- Carry out tolerance reviews on 2D / 3D drawings to ensure reasonable tolerances for part-level manufacturing and assembly.
- Perform DOE to define process parameter windows, set up and qualify process equipment by performing process validation activities.
- Conduct statistical analysis for process stability monitoring and identify opportunities for cycle time and productivity improvement using tools such as Cpk, DOE, and SPC.
- Support PFMEA and risk assessment for new products and manufacturing processes.
- Explore new tools, jigs & fixtures and automation opportunities during assembly process development.
- Conduct proofs of concept (POC) to ensure process stability at the initial development phase.
- Drive improvements for critical processes such as extrusion, molding, tip forming, assembly, packaging, and sterilization stability.
- Assess the consistency of measuring methods and equipment accuracy & repeatability through GR&R.
- Collaborate with R&D and cross-functional teams to determine suitable product test methods and equipment.
- Optimize process flow, line layout and assembly methods to eliminate waste, and drive improvements in packaging processes.
- Review tooling to ensure product design requirements and stability of quality.
- Track project schedules, provide status updates, maintain project databases, and document projects (independently or as input to a larger plan).
- Generate Project Validation Plans (PVP) and other process validation requirements (URS, FAT, SAT, IQ, OQ, PQ) and execute validation activities with documentation.
- Coordinate sample build planning and assemble samples for evaluation.
- Ensure changes are implemented through proper Change Request Forms (CRF) and Sustaining Intake Forms.
- Maintain effective occupational safety and health management in compliance with the Occupational Safety and Health Act 1994 and other regulatory requirements.
- Ensure compliance with Quality System Regulation (QSR), CMDCAS, MDD 93 / 42 / EEC, MDR, ISO 13485 and other relevant standards.
Qualifications
Education / Experience Requirements
Bachelor Degree in Mechanical Engineering, Polymer Engineering or equivalent technical discipline, or an advanced degree or equivalent work experience.
Experience
Experience in a Medical Device / manufacturing environment with demonstrated expertise in relevant engineering and project management.Knowledgeable in effective and efficient product manufacturing processes.Strong technical and problem-solving skills to ensure successful project execution and implementation.Sense of urgency and commitment to project schedules; ability to work in a dynamic, international environment.Experience in Medical Device industry including FDA requirements, Design Control, Process Validation and ISO 13485 is advantageous.Hands-on experience in process automation, instrumentation, technical drawing, extrusion, and molding is an advantage.Understanding that documentation is part of the job.Specialized Skills / Other Requirements
Note : As with all positions, responsibilities may evolve and change over time. Teleflex is an equal opportunities employer.
Teleflex follows a comprehensive hiring process. We do not accept unsolicited resumes from agencies or third-party firms, do not make unsolicited job offers, and do not ask for money or equipment purchases up-front. Teleflex and its brands are trademarks of Teleflex Incorporated or its affiliates.
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