Senior Manufacturing Engineer - Instruments

Company Description

Headquartered in San Francisco, CA, Cytovale is a dynamic, late-stage startup focused on developing a faster, more insightful way to diagnose fast-moving and immune-mediated diseases. Cytovale’s IntelliSep test is pioneering a new way of quickly and accurately analyzing white blood cells to stratify a patient’s risk of sepsis. The test simply and clearly determines risk of sepsis using a biomechanical evaluation of white blood cells collected from a standard blood draw, generating results in under 10 minutes. This gives physicians actionable information when they need it most, allowing them to confidently triage suspected sepsis patients quickly and spend more time with those in greatest need. It also helps strained health systems prevent unnecessary treatment, preserve valuable resources, and improve compliance with SEP-1 guidelines.

As the Senior Manufacturing Engineer, you will be a key member of the Operations team. You will represent the company 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 in vitro diagnostic (IVD) system, product testing, troubleshooting, root cause analysis, and implementing process control solutions for the 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 3-5 days a week.

Primary Responsibilities:

• Represent company 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%)

Minimum Qualifications:

• 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

Preferred Qualifications:

• Experience developing/manufacturing capital systems; IVD preferred
• Experience scaling-up MFG
• Principles of Design For Manufacturability (DFM)

EQUAL OPPORTUNITY EMPLOYER - Cytovale is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.