| Location | Campbell, CA |
Qualifications:
BS in Engineering with 8+ years of experience, or MS with 6+ years of experience in the medical device industry
Deep background with single-use devices and consumables
Expertise in pilot and production line setup and validation in controlled environments
Knowledge of FDA QSR, ISO 13485, and MDD/MDR compliance
Deep understanding of GMP, GDP, and Design Control procedures
Experience with ERP, MRP, and documentation control systems
Familiarity with contractual frameworks including supply, services, and non-disclosure agreements
Responsibilities:
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.
Coordinate cross-functional operations project teams from early conceptualization through clinical testing, managing schedules, timelines, and budgets.
Partner with supply chain to track inventory, raw materials, and component requirements per the planned build schedule, maintaining accountability for all issued materials.
Conceptualize and implement manufacturing improvements, tooling, and process technologies to decrease manual operations, improve repeatability, and increase yields.
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).
Conduct time studies, define in-process testing parameters, and lead continuous improvement projects with Quality personnel to resolve yield and compliance issues.