Process Development Leader
The Process Development Leader will be responsible for leading manufacturing engineering activities, developing processes for new devices, and driving continuous improvement across production systems.
Main Responsibilities:
1. Equipment and Process Validation: Lead equipment validations (IQ/OQ/PQ) and support supplier-led process validations.
2. Documentation and Technical Leadership: Develop and maintain high-quality process documentation. Manage the Manufacturing Engineering team. Serve as the subject matter expert for all manufacturing engineering activities.
3. Product Labelling Systems: Design, implement, and ensure compliance of product labelling systems. Manage label creation using platforms such as BarTender.
4. Manufacturing Systems Optimization: Lead line balancing, layout redesign, and process flow improvements using Lean Six Sigma tools. Develop jigs and fixtures to improve yield, throughput, and error-proofing.
5. Cross-Functional Collaboration: Work closely with R&D teams on Design for Manufacture (DFM) improvements.
Required Qualifications & Experience:
* Engineering or relevant technical degree.
* 8+ years relevant experience in a manufacturing environment, including at least 5 years in the medical device industry in roles such as Senior Manufacturing Engineer, Senior Process Development Engineer, Project Engineer.