Provide daily technical and operational support across products, processes, and equipment to drive unit performance across Safety, Quality, Service, and Cost.
Key Responsibilities
- Technical Leadership: Lead process improvements, technical troubleshooting, and Lean initiatives to optimize quality, throughput, and unit costs.
- Compliance & Quality: Maintain strict compliance with GMP, ISO standards, and quality system regulations while keeping patient safety as the top priority.
- Validation & Engineering: Oversee equipment installation, process validation (OQ/PQ), and the creation of compliant technical documentation.
- Project & Capacity Management: Plan and execute sustaining and capacity projects across sites, maintaining capacity models and advance planning for capital requirements.
- Cross-Functional Collaboration: Partner with EHS, Quality, and corporate Engineering teams, supporting new product introductions (NPE) and environmental impact assessments.
Qualifications & Requirements
- Education: Level 8 Degree in Engineering or a relevant discipline.
- Experience: Minimum 2 years in an engineering role within Medical Devices or a similar regulated industry.
- Core Competencies: Strong grounding in equipment qualification, process validation (OQ/PQ), and systematic problem-solving.
- Systems & Tools: Familiarity with MES, SAP, or PLM systems (e.g., Windchill) is a strong plus.
- Project Skills: Proven ability to manage multiple projects, timelines, and cross-functional teams independently.
