Product Engineer II (m/w/d) - Sustaining Engineering
Core
Sustaining Engineer responsible for the post-market lifecycle of marketed medical devices, ensuring safety, quality, manufacturability, and regulatory compliance.
Role type
Mid-level IC product engineer (medical devices)
Builds
Marketed medical devices for aortic disease treatment
Domain
Medical devices / Biomedical engineering
Required skills
Risk-based decision making, Design Control, Change Control, Root Cause Analysis, Statistical methods, Technical documentation, Supply chain risk assessment, Regulatory compliance (FDA/ISO 13485)
Preferred skills
Advanced degree in Biomedical Engineering, Mechanical Engineering, or related field
Technologies
None stated
Responsibilities
Manage assigned marketed medical devices throughout their post-market lifecycle; Evaluate technical problems and develop risk-based action recommendations; Lead defined or medium-complex changes to product design, materials, manufacturing processes, and documentation; Conduct technical investigations including non-conformities, deviations, complaints, and CAPAs; Develop and implement corrective and preventive actions; Assess technical risks in the supply chain and develop solutions to ensure supply continuity; Ensure technical accuracy and currency of engineering documentation; Support internal and external audits and regulatory inspections.
Seniority
Mid-level, hands-on IC