Information Technology_USA - USA_Senior Engineer

Role Descriptions: Roles ResponsibilitiesTRB (Technical Review Board) Role Expectations ScopeThe TRB is a cross-functional review forum where representatives from- Technical community- Life sciences- Product engineering- Process engineering- Software systems engineering- Product design- Regulatory affairs- Quality assurance- Quality engineeringevaluate attributes| risks| and impacts related to change management. A key responsibility of TRB is preserving and maintaining the original design intent when changes are proposedensuring safety| performance| regulatory compliance| and product quality are not compromised.The selected candidate will- Interact with all SMEs- Lead and navigate complex discussions- Identify gaps| risks| and missing information- Drive alignment and decision-making- Ensure change meets quality and compliance expectationsKey Responsibilities TRB Leadership- Lead| moderate| and document TRB meetings with cross-functional stakeholders.- Drive structured| objective technical and quality discussions.- Evaluate design intent| risks| usability| and regulatory implications.- Facilitate decision-making and ensure ownership of actions and risks.Key Responsibilities Quality Compliance- Apply deep understanding of Medical Device QMS (ISO 13485| 21 CFR 820).- Review documentation associated with change management (ECOs| design updates| deviations| CAPAs).- Lead and review risk assessments per ISO 14971.- Ensure compliance with design control and technical documentation requirements.Key Responsibilities Cross-Functional Collaboration- Engage SMEs across technical| engineering| RAQA| and manufacturing teams.- Explain required changes and clarify expectations.- Communicate assertively push back and say no when quality or compliance is at risk.- Act as primary bridge between change owners and review teams.Process Improvement- Evaluate and improve TRB and change management workflows.- Identify gaps| bottlenecks| and inefficiencies.- Drive continuous improvement initiatives.
Essential Skills: Senior Quality Engineer TRB (Technical Review Board) Lead
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & Regulations~EIS : MDD Risk Management
Experience Required: 6-8