Job SummaryThe 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.
Education- Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related field); Master's degree preferred.
Required Experience & Competencies- 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.
