Manufacturing/QA Engineer
Core
Develop, validate, document, and support manufacturing processes and equipment controls for electro-mechanical medical devices to ensure compliance with specifications and regulations.
Role type
Manufacturing/QA Engineer
Builds
Electro-mechanical medical devices (cardiac management systems)
Domain
Medical device manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
electro-mechanical process development, quality assurance, Lean/Six-Sigma, process validation, regulatory compliance, statistical process control (Gage R&R, Cpk), process flow design, global process launch support
Preferred skills
manufacturing standards implementation, value improvement project management, operational efficiency analysis
Technologies
Lean/Six-Sigma methodologies, Gage R&R, Cpk analysis tools
Responsibilities
Establish and validate manufacturing/service processes to meet quality requirements and timeframes; Analyze quality information to proactively identify and resolve potential problems; Design and optimize operation sequences and process flows for production efficiency; Ensure operations measurement systems are capable and process controls are in place; Manage the launch of manufacturing processes globally with up to 10% international travel.
Seniority
Mid-Senior level (5-8 years experience)