Job Overview
This position offers a great opportunity for an accomplished professional to excel in the field of high-speed automation for micro assemblies.
The role involves leading and being accountable for process development, troubleshooting, and continuous improvement of production processes and equipment in the manufacturing area.
This includes strategic planning and optimization of manufacturing processes.
Key Responsibilities:
1. Oversee and analyze the performance of equipment, machines, and tools using advanced statistical methodologies to resolve complex equipment issues and optimize process parameters to eliminate non-conforming products, low yields, or product quality issues.
2. Champion and drive continuous improvement processes for production areas using structured Process Capability and Lean Six Sigma methodologies, leading cross-functional teams in these initiatives.
3. Create, execute, coordinate, and lead the design of experiments, test methods, protocols, specifications, and validation documentation (IQ/OQ/PQ) and oversee the development and execution of qualification trials/characterization studies.
4. Manage multiple complex projects, generate comprehensive project plans, and lead project teams to drive completion and success, ensuring alignment with strategic objectives.
5. Oversee the maintenance and calibration of critical equipment-systems, ensuring compliance and optimizing maintenance schedules.
6. Interface with cross-functional teams and external vendors to integrate new products, processes, and technologies into the existing manufacturing area, leading the technology transfer and implementation.
7. Lead the development of automated solutions for NPI programs, including new business development opportunities, and provide strategic input on automation strategies.
8. Oversee and approve the qualification of engineering change management, ensuring robust change control processes.
Requirements
* Extensive experience using engineering tools and software packages to design and automate complex manufacturing processes.
* Proven experience in detailed analysis, modeling, and methodologies to validate manufacturing process and tooling design and specifications.
* Extensive experience in creating CAPA, FMEA, SOP's, Control Plans, and performing validation (FAT, SAT, IQ, OQ, PQ).
* Demonstrated ability to effectively communicate manufacturing plans, proposals, and results, and negotiate options at executive management levels.
* Exceptional analytical and problem-solving skills.
* Excellent interpersonal and communication skills.
* A strong aptitude for report writing and data analytics.
* In-depth knowledge of the medical device industry and of 21 CFR, (820, 11), ISO***** specifically in the areas of Change Control and Validation.
About Us
Celestica enables the world's best brands through our recognized customer-centric approach. We partner with leading companies across various industries to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform, and supply chain solutions, we bring global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud.