Manufacturing Engineer
Manufacturing Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
- Manufacturing Engineer GMP FDA KPI ISO Standards Six Sigma Lean Methodology Risk management Validation processes Manufacturing Automation.
- Lead manufacturing programs to drive process improvements cost reductions and quality enhancements.
- Collaborate with R&D Quality Supply Chain and Manufacturing teams to ensure seamless transition from product development to manufacturing.
- Develop comprehensive project plans timelines and budgets to meet business objectives.
- Identify risks and develop mitigation strategies to avoid delays and ensure compliance with regulatory standards.
- Monitor key performance indicators (KPIs) and generate reports to stakeholders.
- Ensure manufacturing processes adhere to Good Manufacturing Practices (GMP) and ISO standards.
- Drive continuous improvement initiatives within manufacturing operations.
- Facilitate communication and collaboration across departments to align project goals and milestones.
- Support validation qualifications and regulatory submissions related to manufacturing processes.
- Experience in leading manufacturing Automation programs.
- Exposure to AI/Gen AI technologies and implementation in the manufacturing site.
- Strong knowledge of GMP FDA ISO standards and regulatory requirements.
- Demonstrated project management expertise preferably PMP or equivalent certification.
- Excellent leadership communication and interpersonal skills.
- Ability to manage multiple projects in a fast-paced dynamic environment.
- Proficiency with manufacturing/ERP software and MS Office Suite.
- Experience in the Medtech Industry. Cardiovascular device manufacturing experience preferred.
- Six Sigma Lean Methodology or other continuous improvement certifications.
- Knowledge of risk management and validation processes.
- Experience in leading manufacturing Automation programs.
Employment Type
Full-time
