
Advanced Manufacturing Specialist
4 days ago
We are seeking a seasoned professional to take on the role of Senior Manufacturing Engineer.
This position offers the opportunity to play a key part in developing and optimizing advanced manufacturing processes for medical devices, supporting business growth and ensuring compliance with international standards.
This senior engineer will be responsible for providing technical leadership and mentorship to engineers and technicians, ensuring stable, efficient, and compliant manufacturing operations.
Key Responsibilities:
- Provide technical guidance and oversight to ensure smooth manufacturing operations.
- Lead complex troubleshooting efforts for equipment, tooling, process, or material issues using advanced problem-solving techniques.
- Drive continuous improvement initiatives using Lean, Six Sigma, and other structured methodologies.
- Own and oversee process and equipment change control activities, ensuring quality and regulatory compliance.
- Lead the strategy, planning, and execution of equipment and process validations.
- Guide root cause investigations for non-conformances and ensure effective corrective and preventive actions.
- Collaborate cross-functionally on new product introductions, risk management, and technology transfers.
- Represent manufacturing engineering in audits and regulatory inspections, ensuring compliance with regulatory requirements.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Manufacturing, Biomedical or related discipline).
- 6-9 years' experience in medical device or pharmaceutical manufacturing, with proven leadership and mentoring responsibilities.
- Strong knowledge of medical device quality standards.
- Demonstrated expertise in process validation and change control.
- Skilled in continuous improvement methodologies (Lean, Six Sigma).
What We Offer:
- Opportunity to work on cutting-edge MedTech manufacturing processes.
- Career development with leadership exposure and cross-functional project ownership.
- Competitive compensation and benefits package.
- A collaborative and innovative team environment.
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