Senior Manufacturing Process Specialist
CurrentResponsible for establishing, qualifying, and improving manufacturing processes for the assembly, troubleshooting, and testing of sophisticated, sensitive, precision medical instruments for neurosurgical and imaging applications.- Evaluate, establish, improve, and qualify manufacturing processes following GMP and SMI’s guidelines by understanding product requirements and applying knowledge of product design, fabrication, assembly, tooling, and materials- Develop, implement, and transfer of manufacturing processes and procedures for new product introductions and continuous manufacturing improvement opportunities- Interaction with all departments to facilitate communication, introducing changes, root cause analysis and lean initiatives- Support or lead outsourcing activities including technology transfer, manufacturers qualifications, training, documentation completion- Support the Production Team by leading technical troubleshooting efforts related to electromechanical systems, computer systems, and imaging systems- Develop, build, and qualify manufacturing testing stations including hardware and software installations, assembly test fixtures/jigs, and other tests equipment as required- Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout while meeting manufacturing process, product, and quality assurance requirements- Provide inputs to the product design for CI initiatives, DFM and serviceability- Develop and update manufacturing work instructions, DMRs and other compliance documentation as required and implement approved changes through ECO process- Assure product and process quality by designing testing methods and establishing standards to confirm manufacturing process capabilities- Provide manufacturing decision-making information and communicate production status, deviations, issues, and general information to manufacturing management- Assist during internal/external audit process