Senior Manufacturing Engineer

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.