Manufacturing Process Lead
6 hours ago
We are seeking an experienced Senior Production Process Engineer to lead and support the development, optimization, and validation of manufacturing processes for our medical devices.
This role involves supporting scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques.
- Key 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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