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Senior Medical Device Engineer
2 days ago
We strive to be at the forefront of medical device manufacturing excellence by investing in top talent like you.
In this pivotal role, you will lead the development, optimization, and validation of manufacturing processes for implantable Class III medical devices, ensuring seamless collaboration with cross-functional teams.
You will spearhead the implementation of advanced manufacturing techniques, drive continuous improvement initiatives, and guarantee compliance with regulatory standards.
To succeed in this position, you must possess a strong background in process development and a passion for driving excellence in medical device manufacturing.
Responsibilities:- Process Development:
- Develop and optimize manufacturing processes for new and existing implantable medical device products.
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and process implementation.
- Design, document, and maintain process workflows, control plans, and standard operating procedures.
- Process Validation and Qualification:
- Conduct process validation activities, including IQ/OQ/PQ for new and modified manufacturing processes.
- Evaluate validation protocols against regulatory standards and execute effectively to meet quality requirements.
- Analyze and document validation results, addressing any deviations or non-conformances.
- Collaborate with maintenance and equipment teams to ensure optimal performance of manufacturing equipment.
- Continuous Improvement:
- Identify and lead continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
- Lead root cause analyses for process failures or deviations, implementing corrective and preventive actions as necessary.
- Work closely with cross-functional teams to align on process requirements and project timelines.
- Provide technical expertise and training to manufacturing staff on new processes, equipment, and quality standards.
- Regulatory Compliance and Documentation:
- Ensure all production processes comply with medical device regulations and standards.
- Maintain comprehensive documentation related to process design, validation, and improvement activities.
- Participate in audits and regulatory inspections, providing technical support and documentation as required.
- Equipment Management:
- Collaborate with maintenance and equipment teams to ensure optimal performance of manufacturing equipment.
- Support the installation and validation of new equipment, ensuring it meets process requirements and regulatory standards.
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