Job Description:
We are seeking a seasoned Senior Manufacturing Engineer to join our team. As a key member of our medical devices group, you will be responsible for designing and developing robust manufacturing processes to ensure consistent product quality.
You will optimize equipment and process technologies to enable the successful scale-up and transfer of efficient processes into full production. You will also collaborate with cross-functional teams to facilitate design, validation, and transition of new medical devices from development through to manufacturing.
In addition, you will manage and support external vendors in the design, fabrication, and installation of manufacturing equipment. Your expertise will drive continuous improvement and innovation across existing equipment and processes to support New Product Introductions (NPIs).
You will prepare, maintain, and update comprehensive process and manufacturing documentation. Your strong analytical and problem-solving skills will help author and execute validation and qualification protocols for manufacturing equipment and processes.
Required Skills and Qualifications:
* Strong technical or engineering background in new product development and sustaining engineering within the medical device industry.
* In-depth understanding of medical device regulations, including FDA 21 CFR Parts and, design controls, ISO, regulatory audits, and international environmental standards.
* Bachelor's degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
* Minimum of 5 years' experience in the medical device sector.