Senior Application Engineer, Single-Use Bag Systems

Sanisure; Camarillo, Northern (CA, KY); Hybrid; USD 120,000 - 150,000; Full time

Job summary

SaniSure, a Camarillo-based biotech device manufacturer, seeks an Application Engineer for Bags and Bag Systems to translate customer requirements into engineered bag solutions. You’ll act as the technical liaison between Sales, Product Management and customers, guiding product configuration, quotes, design inputs and application troubleshooting across the bag portfolio.

Requires 7+ years in biotech/pharma or medical device manufacturing, CAD (2D/3D), GMP experience and strong cross‑functional

Qualifications

• Bachelor's degree in Engineering required; Master's preferred.
• 7+ years in biotech/pharma or medical device manufacturing.
• CAD proficiency for 2D/3D models, drawings, and BOMs.
• Make/buy analysis and supplier qualification experience.
• GMP experience and strong documentation discipline.
• Strong customer-facing communication and proposal management.

Responsibilities

• Develop deep product knowledge of SaniSure's bag portfolio to provide technical expertise.
• Serve as a customer-facing technical resource and lead inquiries, proposals, and counterproposals.
• Translate customer specifications into engineering inputs, drawings and BOMs for bag assemblies.
• Support quoting with make/buy analyses, supplier engagement, and pricing guidance.
• Apply regulatory knowledge to ensure compliant bag solutions.
• Collaborate with Manufacturing on DFMA and DTC considerations.
• Lead or support CAPAs related to bag product quality issues.
• Participate in NPI activities including validation and process optimization.
• Assist audits, respond to NCRs, and drive design documentation improvements.
• Mentor junior engineers and drafters.

Skills

Customer-facing

Project management

Problem solving

Regulatory awareness

Mentoring

Education

Bachelor's in Engineering

Master's degree preferred

Tools

CAD 2D/3D

BOM & drawings

MS Office

Job description

SaniSure, a Camarillo-based biotech device manufacturer, seeks an Application Engineer for Bags and Bag Systems to translate customer requirements into engineered bag solutions. You’ll act as the technical liaison between Sales, Product Management and customers, guiding product configuration, quotes, design inputs and application troubleshooting across the bag portfolio.

Requires 7+ years in biotech/pharma or medical device manufacturing, CAD (2D/3D), GMP experience and strong cross‑functional