Equipment Engineer

Equipment Engineer

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.

• 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.
• Deliver robust assembly processes and associated equipment that achieve cycle time, cost, capacity, and quality requirements (MSA, GRR).
• Continue ownership and support of equipment beyond IQ/OQ/PQ qualification and throughout the stabilization period. This includes handling scrap and supply disruptions, equipment/process improvement projects, and overall stabilization of the process while ramping up production prior to LCE/Plant handoff.
• Knowledge of medical-specific assembly technologies, equipment supplier base, and supplier capabilities.
• Knowledge of equipment cost and lead time.
• Provide significant input to the capital budget estimate.
• Understand the connection between product requirements and each assembly station.
• Generate equipment requirements.
• Lead the DFA assessment for each assigned station and provide feedback to the design team.
• Provide oversight and leadership of the process characterization strategy for each assigned station.
• Deliver component, assembly, and supply chain strategy project deliverables at each phase of the project.
• Drive critical product requirements cascading to component and assembly processes.
• Transform design information, including component drawings and models, product requirements, AFMEA, and DFMEA, into a robust manufacturing process.
• Identify and escalate potential development-related risks and provide input to the project RISDA.
• Develop strategies to mitigate identified risks.
• Proactively develop strategies to rapidly react to design changes and provide flexibility through standardized/family tools, insert strategies, modularity, and similar approaches.
• Provide critical input to the development of project schedules, expense budgets, and capital budgets, including capital tooling and qualification costs and schedules.
• Assist the LDE and Project Director with identifying required development resources.
• Escalate needs appropriately to help prioritize development team tasks.
• Act as the liaison between the Design team and component/equipment suppliers.
• Provide the "voice of manufacturing" to influence design and include DFM/DFA feedback while maintaining Design Intent.

• Equipment Design
• Equipment Development
• Equipment Manufacturing
• Manufacturing Automation
• Equipment Commissioning
• Factory Acceptance Testing (FAT)
• Assembly Equipment
• Manufacturing Equipment
• Process Validation
• IQ/OQ/PQ
• Software Validation
• DFM
• DFA
• MSA
• Gage R&R / GR&R
• FMEA / DFMEA / EFMEA / AFMEA
• Process Characterization
• Equipment Requirements
• Medical Device Manufacturing
• Equipment Supplier Management
• Manufacturing Process Development
• Risk Management
• Capital Equipment
• Product Commercialization
• GMP
• ISO 13485
• FDA-Regulated Environment

• B.E./B.Tech in Mechanical, Manufacturing, or Industrial Engineering.
• 5–10 years of experience in medical device manufacturing and equipment development.
• Strong experience in equipment design, development, FAT, commissioning, and manufacturing automation.
• Experience with assembly equipment development and manufacturing processes.
• Experience with IQ/OQ/PQ, DFM/DFA, MSA, Gage R&R, FMEA, and process characterization.
• Medical domain experience is required.
• Strong cross-functional collaboration, technical problem-solving, supplier management, and risk management skills.