Staff/Sr. Manufacturing Engineer, Consumables

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.