Role Overview:This role focuses on ensuring quality and compliance within the medical device industry, specifically for a surgical robotics platform. The engineer will be responsible for design transfer, production support, and maintaining the Quality Management System (QMS) in adherence to regulatory standards.
Key Responsibilities:- Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
- Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
- Investigate non-conformances (NCs) using root cause analysis and drive CAPA within the QMS framework.
- Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
- Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
- Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements.
- Collaborate with cross-functional teams to deliver quality-compliant outcomes.
- Interpret and apply medical device regulations and standards to projects and processes.
- Support audits and regulatory inspections, ensuring timely closure of actions.
Required Skills:- Strong understanding of Medical Device Quality Systems and regulatory compliance requirements.
- Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation).
- Strong expertise in design transfer activities, including DHF ? DMR transition and compliance with FDA 21 CFR 820 & ISO 13485.
- Sound knowledge of Medical Device Regulations, including MDD and MDR.
- Proven experience in Non-Conformance (NC) management, CAPA processes, and internal/external audits.
- Expertise in Medical Device Risk Management, with the ability to identify both apparent and less-obvious risks.
- Practical experience with Application, Process, Design, and System FMEA methodologies.
- Proficient in statistical tools and techniques, including Design of Experiments (DOE).
- Capable of performing advanced descriptive and non-parametric statistical analyses.
- Experienced in leveraging advanced statistical methods for reliability prediction and data-driven decision making.
- EIS: Medical Device & Regulations
Qualifications:- 8+ years of experience in Medical Device Quality & Compliance.
- Strong knowledge of ISO 13485, 21 CFR 820, MDD/MDR.
- Expertise in Design Transfer Activities.
- Hands-on experience in QMS, NC, CAPA, and Audits.
- Strong expertise in Risk Management (ISO 14971), including FMEA and data-driven quality decisions.
Preferred Skills: 
