Role Overview
In Operations, you will provide daily engineering support for medical device product lines, processes, and equipment. You will be responsible for ensuring production goals, specifically quality, delivery, cost, and safety, are met while maintaining strict adherence to medical device regulatory standards.
Key Responsibilities
- Root Cause Analysis: Lead issue investigations using structured problem-solving methodologies (e.g., Six Sigma, DMAIC, 5 Whys) to identify and implement permanent corrective actions.
- Cross-Functional Collaboration: Actively partner with Quality, R&D, and Supply Chain teams through face-to-face and virtual forums to resolve production bottlenecks.
- Process Optimization: Develop and analyze specifications for processes, products, and materials. Use data-driven insights to improve yield and productivity.
- EHS & Compliance: Evaluate new equipment, processes, or chemicals for environmental and safety impacts in conjunction with EHS, ensuring all changes meet safety protocols.
- Equipment Ownership: Assume primary engineering responsibility for specialized manufacturing equipment and automated processes within a Grade A-D/ISO Class 5-8 cleanroom environment.
- External Liaison: Interface with vendors, technical consultants, and potentially clinical partners to troubleshoot equipment or source materials.
- Quality Excellence: Build Quality into all aspects of work. Maintain 100% compliance with ISO 13485 and FDA 21 CFR Part 820 requirements through meticulous documentation and adherence to Standard Operating Procedures (SOPs).
Education & Experience
Education: NFQ Level 8 Honours Bachelor's degree in a STEM discipline (Mechanical, Biomedical, or Manufacturing Engineering preferred).
- Experience: Minimum of 1 year of professional experience in a Medical Device manufacturing environment.
- Regulatory Knowledge: Proven understanding of working within a regulated Quality Management System (QMS), including experience with Change Control and NCR/CAPA processes.
- Technical Proficiency: Demonstrated ability to troubleshoot manufacturing equipment and a working knowledge of process validation (IQ/OQ/PQ).
- Communication: Strong interpersonal skills with the ability to translate technical issues into clear updates for cross-functional stakeholders.
- Autonomy: Proven ability to work independently with minimal supervision while maintaining high levels of initiative in a fast-paced production environment.
