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Staff/Sr. Manufacturing Engineer, Consumables
Job Description
Qualifications:
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BS in Engineering with 8+ years of experience, or MS with 6+ years of experience in the medical device industry
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Deep background with single-use devices and consumables
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Expertise in pilot and production line setup and validation in controlled environments
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Knowledge of FDA QSR, ISO 13485, and MDD/MDR compliance
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Deep understanding of GMP, GDP, and Design Control procedures
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Experience with ERP, MRP, and documentation control systems
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Familiarity with contractual frameworks including supply, services, and non-disclosure agreements
Responsibilities:
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Oversee production builds for single-use devices and consumables, managing both in-house activities and contract manufacturing relationships to ensure compliance with product plans and regulatory requirements.
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Coordinate cross-functional operations project teams from early conceptualization through clinical testing, managing schedules, timelines, and budgets.
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Partner with supply chain to track inventory, raw materials, and component requirements per the planned build schedule, maintaining accountability for all issued materials.
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Conceptualize and implement manufacturing improvements, tooling, and process technologies to decrease manual operations, improve repeatability, and increase yields.
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Collaborate with R&D and Quality to select suppliers, author manufacturing SOPs, and develop Manufacturing Process Instructions (MPIs), Lot History Records (LHRs), and Device History Records (DHRs).
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Conduct time studies, define in-process testing parameters, and lead continuous improvement projects with Quality personnel to resolve yield and compliance issues.