R&D Engineer I_Product
Core
Support R&D projects by managing design controls, regulatory documentation, and technical transfer to ensure product safety, efficacy, and compliance with quality systems and regulations.
Role type
R&D Engineer I (Regulatory & Design Control)
Builds
Medical devices or pharmaceutical products for infectious disease division
Domain
Biopharmaceuticals / Medical Devices
Deliverable
client delivery
Required skills
Design control documentation, regulatory affairs support, technical transfer, quality system compliance, project planning
Preferred skills
Product improvement analysis, internal/external audit support, corrective and preventive action (CAPA) implementation
Technologies
Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Assist in developing project plans and experimental schemes based on quality systems and regulations; Communicate design inputs/outputs to ensure product robustness and reliability; Participate in design assurance for new product development or improvements; Collaborate on technical transfer and product validation; Collect and prepare technical data for registration submissions and product standards; Maintain product design history records; Support internal and external audits and implement corrective actions.
Seniority
Entry-level IC
