Prepare CAD models using SolidWorks and Fusion 360 for manufacturing, ensuring accurate designs for production efficiency.

Execute 3D printing processes, parameter adjustments, and post-processing to ensure high-quality outputs.

Perform mold processing, silicone injection, post-processing, coating application, labeling, and packaging ensuring adherence to Good Manufacturing Practices (GMP) and quality standards.

Conduct detailed inspections and quality checks on final products, utilizing approved measurement standards.

Lead technical process improvement initiatives by defining critical KPI’s and monitoring for trends, analyzing production data, identifying bottlenecks, and implementing solutions to increase product quality, process efficiency and reduce operational costs.

Perform equipment calibration, preventive maintenance, and troubleshooting for advanced manufacturing tools, including 3D printers, mold processing equipment, and coating application devices.

Collaborate closely with R&D to prototype design concepts for jigs/fixtures to reduce operator strain, suggest design improvements to reduce post-processing time, and drive scheduling of post-processing to reduce product lead time.

Responsible for purchasing, incoming inspections, inventory tracking.

Create, maintain, and develop Device Master Records (DMRs) and Device History Records (DHRs) follow ISO 13485 and FDA regulations.

Develop and refine Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure consistency and compliance across all production activities.

Promote and participate in JHSC initiatives and compliance as directed by the Joint Health and Safety Committee (JHSC).

Support the implementation of data-driven decision-making tools and software solutions to enhance production capabilities.

Cross-Functional Collaboration and Continuous Improvement:

Partner with engineering, quality, and operations teams to design and implement technical solutions, improving product quality and production throughput.

Contribute to research and development (R&D) projects by providing technical support, feedback on design iterations, and prototype testing as part of production development.

Other duties as assigned.

Adhere to all requirements of the Quality Management System.