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Implantable Device Manufacturing Specialist
18 hours ago
We are seeking a highly skilled Implantable Device Manufacturing Specialist to join our team and drive the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices. This role will require around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with expertise in at least Class III products.
A bachelor's degree in engineering or a related field is required, and a master's degree is preferred. The ideal candidate will have strong analytical skills, attention to detail, and excellent communication skills.
Key Responsibilities:
- Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
- Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
Process Validation and Qualification:
- Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
- Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
- Analyze and document validation results, addressing any deviations or non-conformances.
Continuous Improvement and Optimization:
- Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
- Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
Required Experience & Qualifications:
- Around 5-8 years of experience in process engineering, within the pharmaceutical or medical device industry with experience in at least Class III products.
- Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
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