US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
· Lead the manufacturing of implantable spine devices.
· Implements, organizes, and scales up manufacturing processes from pilot line to product launch.
· Review PCB and mechanical assembly drawings for complete notes, and attention to DFM
· Develop manufacturing plans, project timelines, requirements, and process flow.
· Conduct manufacturing related design reviews and train in-house personnel.
· Develop and manage verification and validation activities for process changes and new products related to hardware, software, electronic packaging, and overall functional performance.
· Manage installation of new equipment including qualification activities (IQ / OQ / PQ).
· Brainstorm solutions to resolve technical issues encountered during manufacturing.
· Create and maintain work instructions (MPI’s), DHRs, BOM’s, and ancillary process documents.
· Drive process improvements affecting yields, capacity increases, cycle time and cost reduction initiatives.
· Participate in manufacturing risk management activities such as design and process FMEAs
· Interface frequently with internal departments including R&D, Regulatory, Quality, Marketing
· Build and cultivate relationships with industry partners, electronics contract manufacturers, test houses, and other solution providers as needed to support the project.
· Oversee initial product builds (engineering units, pilot units, process validation units and coordinate a smooth transfer of new products to production.
· Monitor status of new product manufacturing tasks and ensure effective execution of tasks according to required policies, procedures, and regulations
· Support the task of integrating new manufacturing fixtures and equipment in production with emphasis on mistake-proofing
· Work in accordance with Quality system procedures and actively enforces its objectives
- FDA design controls and clinical good manufacturing processes (cGMP)
- ISO 13485 / CE Mark
Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.Medical device preferred