Application Engineer - Needle Fill-Finish Manufacturing

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. Job Summary The Application Engineer for Needles and Fill Finish works closely with Sales and Product Line Management to translate customer requirements into engineered single-use filling needle solutions for aseptic fill-finish manufacturing. 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 filling needle product lines used in final fill operations. Essential Functions Develop deep product knowledge of SaniSure's filling needle 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 filling needle 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 aseptic fill-finish manufacturing, including EMA Annex 1, first-air principles, aseptic manufacturing standards, and current FDA/EMA regulatory requirements, to ensure needle solutions meet customer compliance needs. Collaborate with Manufacturing to evaluate Design for Manufacture & Assembly (DFMA) and Design to Cost (DTC) perspectives for filling needle assemblies. Lead or support root cause analyses and corrective/preventative actions (CAPAs) related to filling needle product complaints and quality issues. Participate in New Product Introduction (NPI) activities including product validation, process optimization, and post-commercial improvements for needle products. Support audits, respond to NCRs, and drive continuous improvement in design documentation and engineering change processes. Travel to customer sites as required to support technical investigations, product trials, and application assistance. Travel anticipated up to 20%. Provide technical direction and guidance to less experienced Engineers and Drafters. Perform other duties as assigned. Education Bachelor's degree in Engineering (Mechanical, Biomedical, Materials, or related…