GIS Team Member - GISTM

Fully understand the equipment development road map (TR011027). Understand equipment concept creation, review approval, build, run off, FAT, software validation, IQ, OQ, PQ road map requirements. Fully understand the equipment development procedure WE0179 and associated deliverables including ERR, ESRR, EFMEA, and WRAPS/Safety/Ergo assessments. Delivers robust assembly process and associated equipment that achieves cycle time, cost, capacity, and quality requirements (MSA, GRR). Continues ownership and support of equipment beyond IQ/OQ/PQ qualification and throughout stabilization period. This includes handling scrap and supply disruptions, equipment/process improvement projects, and overall stabilization of process while ramping up production prior to LCE/Plant handoff. Knowledgeable about medical specific assembly technologies, the equipment supplier base and the capabilities of the suppliers. Knowledgeable about equipment cost and lead time. Provides significant input to the capital budget estimate. Understand the connection between product requirements to each assembly station. Generate equipment requirements. Leads the DFA assessment for each assigned station, provides feedback to the design team. Oversight and leadership of the process characterization strategy for each assigned station. Delivers component, assembly, and supply chain strategy project deliverables at each phase of the project. Drive critical product requirements cascading to component and assembly processes. Understand how to transform design information (component drawings and models, product requirements, AFMEA, DFMEA) into a robust manufacturing process. Identifies and escalates potential development related risks and provides input to the project RISDA. Develops strategies to mitigate those risks. Proactively develops strategies to rapidly react to design changes and provide flexibility through use of standardized/family tools, insert strategies, modularity, etc. Provides critical input to the development of the project schedule, expense and capital budgets. This may include capital tooling and qualification costs and schedules. Assists the LDE and Project Director with identifying required development resources. Escalates needs appropriately to help with prioritization of development team tasks. Acts as the liaison between the Design team and the component/equipment suppliers. Provides “voice of manufacturing” to influence design and include DFM/DFA feedback while maintaining Design Intent.

Mechanical, Manufacturing, or Industrial Engineer with 5-10 years of experience in medical device equipment development and manufacturing. Expertise in assembly equipment development, process validation (IQ/OQ/PQ), DFM/DFA, MSA, Gage R&R, FMEA, and process characterization. Proven ability to develop robust manufacturing processes, manage equipment suppliers, support product commercialization, and drive continuous improvements in GMP, ISO 13485, and FDA-regulated environments. Strong cross-functional collaboration, technical problem-solving, and risk management skills.., B.E./B.Tech in Mechanical, Manufacturing, or Industrial Engineering with 5-10 years of experience in medical device manufacturing and equipment development. Medical domain experience

• $13.00-14.50 per hour The Fresh Market & You:: Our mission is to make everyday eating extraordinary for our guests, and we are looking for a new team member who will commit to helping us deliver on th…

• 1 day ago + *

Produce Team Member The Fresh Market

• Cincinnati, OH

• $13.00-14.50 per hour The Fresh Market & You:: Our mission is to make everyday eating extraordinary for our guests, and we are looking for a new team member who will commit to helping us deliver on th…

• 1 day ago +