Jobs at SaniSure

Designs and configures single-use bioprocessing bag solutions by translating customer requirements into engineering inputs, drawings, and bills of materials. Supports quoting, supplier qualification, root cause analysis, CAPAs, audits, NPI, validation, manufacturing optimization, and continuous improvement. Serves as a customer-facing technical liaison while providing guidance to sales, manufacturing, suppliers, and junior engineering staff.

Leads value analysis and value engineering initiatives to reduce product and manufacturing costs. Responsibilities include VAVE, design-to-cost, design-for-manufacture and assembly, sourcing analyses, product verification, production transfer, capital equipment qualification, yield improvement, supplier changes, and technical documentation. The role collaborates with Procurement, Finance, Design Engineering, Operations, Quality, and suppliers while ensuring design and process changes meet quality standards.

Designs and configures single-use filling needle solutions for aseptic pharmaceutical fill-finish applications. Translates customer requirements into engineering inputs, drawings, and bills of materials; supports quoting, supplier qualification, manufacturing integration, troubleshooting, root cause analysis, CAPAs, audits, and new product introduction. Provides customer-facing technical guidance and supports final-fill investigations and trials, with travel up to 20%.

Leads manufacturing process engineering, validation, continuous improvement, and new product introduction readiness in a GMP medical device environment. Develops pFMEAs, control plans, SOPs, process qualifications, and validation protocols; investigates root causes and CAPAs; analyzes SPC and process capability data; supports costing, capacity planning, equipment maintenance, audits, and regulatory compliance. Collaborates with Operations, Quality, R&D, and other teams to improve efficiency, reduce waste, and sustain compliant production processes.

Develop and maintain 2D/3D engineering drawings, bills of materials, and product documentation for customer-specific products. Manage engineering changes, revision control, and ERP/MRP documentation while collaborating with engineering, manufacturing, quality, supply chain, and product teams. Support new product introductions, resolve manufacturing documentation issues, prepare technical reports, ensure audit readiness, and improve drafting and document-control processes.