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
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $35.71/hr.
