Senior Manufacturing Engineer
We are seeking an experienced and skilled Senior Manufacturing Engineer to join our team. This role 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 position is ideal for an engineer with strong leadership skills, a passion for continuous improvement, and a proven track record in medical device manufacturing.
Key Responsibilities:
* Provide technical leadership and mentorship to engineers and technicians, ensuring stable, efficient, and compliant manufacturing operations.
* Lead complex troubleshooting efforts for equipment, tooling, process, or material issues using advanced problem-solving techniques.
* Drive continuous improvement initiatives using Lean and Six Sigma 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 (IQ, OQ, PQ).
* Guide root cause investigations for non-conformances and ensure effective corrective and preventive actions (CAPA).
* Collaborate cross-functionally on new product introductions, risk management (FMEAs), and technology transfers.
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 (ISO 13485, FDA QSR).
* Demonstrated expertise in process validation (IQ/OQ/PQ) and change control.
* Skilled in continuous improvement methodologies (Lean, Six Sigma).
What's on Offer:
* Opportunity to work on cutting-edge MedTech manufacturing processes.
* Career development with leadership exposure and cross-functional project ownership.
* Competitive salary and benefits package.
* Collaborative and innovative team environment.