Senior Manufacturing Engineer - #1090782

Essential Duties and Responsibilities:

Include the following. Other duties may be assigned.

• Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
• Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
• Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
• Improve efficiency by analyzing workflow, space, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Lead process qualifications and validations, including equipment and material specifications.
• Ensure product and process quality through testing and establishing standards.
• Provide decision-making information by calculating costs and reviewing schedules.
• Prepare reports by analyzing and summarizing trends.
• Maintain equipment by coordinating maintenance and repairs.
• Ensure Health & Safety, including accident investigation and corrective action.
• Investigate and evaluate new process technologies.
• Mentor and guide junior engineers by providing technical support, fostering professional development, and facilitating knowledge transfer.
• Lead cross-functional teams to drive continuous improvement initiatives and achieve operational goals.
• Develop and implement strategic plans for process improvements and new technology integration.
• Collaborate with senior management to align engineering activities with business objectives.
• Monitor industry trends and advancements to ensure the company remains competitive and innovative.
• Comply with EHS, ISO13485, GMP, FDA regulations, and GDP requirements.
• Any other project or duties as assigned. 

Education/Experience and Qualifications:

• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within the company.
• Proficient in DOE and statistical techniques (SPC)
• Knowledgeable in defining process capabilities and control charting.
• Strong and meticulous in documentation and record management. Ability to manage Engineering Change Order. Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Proficiency with CAD software is required.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation. Must be willing to work in a fast-paced environment with minimum supervision. 
• Availability to travel if required.