Job SummaryThe 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 field); Master's degree preferred.
Required Experience & Competencies- 7+ years of engineering experience in a biotechnology, pharmaceutical, or medical device manufacturing environment.
- Experience with filling needle design, assembly, or application engineering for aseptic fill-finish applications preferred.
- Knowledge of final fill manufacturing processes; familiarity with EMA Annex 1, aseptic processing, first-air principles, and current FDA/EMA regulatory expectations.
- Hands-on experience with final fill machine integration or final fill assembly design is a strong plus.
- Experience with precision fluid-path component design, including leak-proof assemblies and molded plastic parts for fluid handling applications.
- 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.
- Preferred experience:
- Single-use filling needle or precision fluid-path consumable design and development.
- Experience working with filling machine OEMs (e.g., Syntegon, Groninger, Getinge) or final fill equipment suppliers.
- Exposure to CDMO fill-finish operations.
