Production Optimization Expert
5 hours ago
We are seeking a highly skilled Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our medical devices.
This role involves working closely with cross-functional teams to implement advanced manufacturing techniques and drive continuous improvement initiatives to enhance manufacturing capabilities while ensuring compliance with regulatory standards.
- Main Responsibilities:
- Lead the design, development, and optimization of manufacturing processes for new and existing medical device products.
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
- Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
Requirements:
- Around 5-8 years of experience in manufacturing engineering or process engineering, preferably within the medical device, pharmaceutical, or regulated healthcare industry.
- Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
- Experience of freeze drying and sterilization processes, preferably EtO and E-beam.
- Proficiency in process design and validation methodologies, including IQ/OQ/PQ.
- Strong understanding of ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulatory requirements.
- Experience with statistical process control (SPC), Design of Experiments (DOE), and root cause analysis.
- Familiarity with CAD software and process simulation tools.
- Advanced skills in data analysis and reporting.
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