
Manufacturing Efficiency Specialist
6 hours ago
We are seeking a highly motivated and experienced Senior Production Process Engineer to join our team at Nordberg Medical AB. The successful candidate will be responsible for leading and supporting the development, optimization, and validation of manufacturing processes for our medical devices.
Key Accountabilities:- Process Optimization: Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
- Collaboration with Cross-Functional Teams: Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
- Continuous Improvement: Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
- 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.
- Fluency in English (verbal and written).
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