How you match
01Skills
02Risk ManagementReliability engineeringDesign transferGood Documentation PracticesDesign controlsQuality assuranceFailure Mode and Effects Analysis (FMEA)Technical documentation (English)GxP complianceRegulatory Compliance in MedicineProject management softwareVerification engineering
The role
0301Lead and facilitate Failure Mode and Effects Analysis (FMEA) workshops with cross-functional engineering teams
02Identify hazards and evaluate risks within the product risk management process
03Review and update hardware and software safety and reliability concepts, including functional safety aspects
04Oversee test execution and documentation required for certification board (CB) reports
05Maintain and update technical documentation in accordance with internal and external standards
06Plan, coordinate, and report work packages and project activities to stakeholders
Requirements
↳Degree in Electrical Engineering, Mechanical Engineering, Software Engineering, Physics, or a related field
↳More than 3 years of experience in product development
↳Experience in GMP-regulated environments, including:
↳Design Controls
↳Good Documentation Practice (GDP)
↳Design Transfer
↳Risk Management
↳Quality Process Compliance
↳Fluent English communication skills
Benefits
