Application Engineer - Single Use Bag Solutions

The Application Engineer for Bags and Bag Systems works closely with Sales and Product Line Management to translate customer requirements into engineered single-use bag solutions. Acting as a key technical liaison between internal engineering and external customers, this role drives product configuration, quoting support, design inputs, and application troubleshooting across SaniSure's bag product lines. Essential Functions

• Develop deep product knowledge of SaniSure's single-use bag portfolio to provide technical expertise to Sales, Customers, and other functional areas.
• Serve as a customer-facing technical resource: confidently lead and respond to application inquiries, technical proposals, and customer counterproposals.
• Translate customer specifications and application requirements into engineering inputs, drawings, and bill of materials for bag assemblies.
• Support quoting activities by performing make/buy analyses, engaging external suppliers for pricing and qualification, and providing technical guidance to the commercial team.
• Apply knowledge of regulatory requirements to ensure bag solutions meet customer compliance needs.
• Collaborate with Manufacturing to evaluate Design for Manufacture & Assembly (DFMA) and Design to Cost (DTC) perspectives for bag assemblies.
• Lead or support root cause analyses and corrective/preventative actions (CAPAs) related to bag product complaints and quality issues.
• Participate in New Product Introduction (NPI) activities including product validation, process optimization, and post-commercial improvements.
• Support audits, respond to NCRs, and drive continuous improvement in design documentation and engineering change processes.
• Provide technical direction and guidance to less experienced Engineers and Drafters.
• Perform other duties as assigned.

• Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related field); Master's degree preferred., * 7+ years of engineering experience in a biotechnology, pharmaceutical, or medical device manufacturing environment.
• Experience with single-use bag design, assembly, and application engineering for bioprocessing.
• Proficient in CAD software (2D and 3D) for building models and assemblies; able to create, read, and interpret technical drawings, BOMs, and specifications.
• Experience performing or supporting make/buy analyses and supplier qualification/onboarding activities.
• Strong customer-facing skills: able to present technical content, manage proposals, and drive technical alignment with external stakeholders.
• Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (RCCA, CAPAs).
• Experience working in a GMP (Good Manufacturing Practice) environment.
• Project management and strong organizational and time management skills. Detail and deadline oriented.
• Adaptable and capable of working in a fast-paced environment; high initiative, sense of urgency, with ability to work independently.
• Strong work ethic with excellent verbal and written communication skills; ability to interact with staff at all levels within and external to the organization.
• Proficient with Microsoft Office Suite.

About SaniSure SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.