Job summary :
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..
Responsibilities :
• 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.
Top Skills:
Equipment design, development, FAT, commissioning, and manufacturing automation.
Additional Information:
• 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