Senior Manufacturing Engineer, Instruments
This key role partners with our Contract Manufacturers (CMs) to ensure Supply, Quality, and Cost targets are achieved for successful clinical operations, and commercialization.
As the Senior Manufacturing Engineer, you will be a key member of the Operations team. You will represent Cytovale with our Contract Manufacturers (CMs) as both the customer and as the technical partner to facilitate Capacity, Quality, and Cost projects as we prepare for initial product launch. Span of responsibilities includes supporting Design Control activities, preparations for commercial launch, partner with R&D to implement product lifecycle management of the Cytovale in vitro diagnostic (IVD) system, product testing, troubleshooting, root cause analysis, and implementing process control solutions for the Cytovale in vitro diagnostic (IVD) system.
Activities may be a blend of strategic supplier development projects, scale-up, implementing Design for Manufacturability (DFM) improvements, and partnering with supplier(s) to realize opportunities for scale and efficiencies.
This position requires to be on-site in the San Francisco office 4-5 days a week.
- Represent Cytovale as a key technical point of contact for our Contract Manufacturer(s) as we prepare for initial commercial launch
- Proactively identify and lead throughput expansion projects necessary to fulfill forecasts
- Support/lead technical projects to improve Quality and reduce Cost
- Lead/manage design change deliverables associated with establishing reliable MFG processes & risk management
- Partner with R&D and CM with New Product Introduction (NPI) projects
- Support MFG non-conformance root cause analysis investigations and mitigations
- Partner with internal QA and CMs to establish/maintain effective component incoming QC inspection, in-line process validations & monitoring, and lot release testing
- Partner with R&D ENG in support of product lifecycle management (PLM) including developing, implementing DFM opportunities, continuous improvement, and mitigating component supply chain issues
- Support/lead projects to qualify additional/alternative suppliers as necessary
- Occasional domestic travel (~25%)
- BS degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related Engineering field
- 5 years of experience in product/process development in Medical Device industry
- Effective experience managing contract manufacturer/supplier
- Effective experience with developing product specifications, MFG Work Instructions, MFG
- Deviations, Non-Conformance Reports, CAPAs
- Effective experience with Risk Management (pFMEA); Process controls & monitoring, and Validation
- Effective experience with Computer Aided Design (Solidworks)
- Effective at critical thinking and managing complex projects
- Good organizational skills as well as strong written/verbal communications skills that could be used successfully in negotiation, influence, and conflict management
- The ability to prioritize tasks, drive process improvements and thrive in a fast-paced environment
- Experience developing/manufacturing capital systems; IVD preferred
- Experience scaling-up MFG
- Principles of Design For Manufacturability (DFM)