Associate Process Engineer
Core
Lead process engineering team to ensure optimal machine up-time, improve yield and quality, and execute automation projects for production.
Role type
Associate Process Engineer
Builds
Medical devices
Domain
Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process engineering, equipment reliability, process capability, validation, project management, capital expenditure management, risk assessment, continuous improvement, cGMP manufacturing knowledge, FDA regulations knowledge, ISO 13485 knowledge, ISO 14971 knowledge
Preferred skills
assembly process design, automation design, tooling & fixtures design, medical device industry experience, pharmaceutical industry experience
Technologies
cGMP, FDA regulations, Medical Devices Regulation (2017/745), ISO 13485, ISO 14971
Responsibilities
Lead process engineering team to ensure seamless support to the value stream, lead automation projects including equipment upgrade, manage engineering efforts to improve yield and quality, lead validation activities, plan and execute equipment maintenance and upgrade, work with cross functional teams to achieve equipment effectiveness, execute continuous improvement projects, account for capital expenditure initiation and spending control, ensure compliance with quality policies and safety regulations
Seniority
Mid-level, hands-on IC
