Engineering Supervisor Process Engineering
Core
Lead and develop a team of process engineers and technicians to support daily manufacturing operations for diagnostic product production, ensuring robust, repeatable processes that meet product specifications and regulatory requirements.
Role type
Senior IC process engineering supervisor (manufacturing)
Builds
Diagnostic medical devices (assays/reagents) for infectious disease testing
Domain
Healthcare diagnostics / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (IQ/OQ/PQ), root cause analysis, Lean manufacturing, Six Sigma, FDA/ISO 13485/GMP compliance, team leadership, equipment qualification, continuous improvement, data-driven decision making, cross-functional collaboration
Preferred skills
In vitro diagnostics (IVD) technologies, automation/robotics/vision systems, statistical analysis tools (Minitab/JMP), DOE, supply chain integration, high-mix/low-volume manufacturing experience
Technologies
Lateral flow, PCR, immunoassays, automated systems, robotics, vision systems, high-throughput manufacturing equipment
Responsibilities
Lead and coach engineering teams to support manufacturing operations; oversee design, control, and improvement of manufacturing processes; drive process validation and equipment qualification activities; troubleshoot manufacturing issues and lead root cause investigations; implement corrective and preventive actions (CAPA); maintain accurate documentation including SOPs and engineering records; collaborate with Quality and Operations to maintain compliance and efficiency.
Seniority
Senior, hands-on IC with team leadership