- Design quality engineer with minimum 10 years of experience in the medical device industry, specializing in product quality complaints management, regulatory reporting, new product design & development, and risk management.
- Experience in handling Medical devices including Active Devices, Software as a Medical Device, Disposables.
- Working on product DHF, design input, design output, product risk management, usability, verification, and validation efforts.
- Extensive expertise in ensuring compliance with global regulatory standards, including FDA (21 CFR Part 820) and EU MDR.
- Proven ability to navigate complex regulatory landscapes, secure product approvals, and facilitate successful product launches.
- Strong background in Biomedical Instrumentation Engineering, coupled with hands-on experience in driving cross-functional collaboration, complaint resolution, and continuous improvement initiatives.
- Proficient at leading complaint investigations, conducting trend analysis, and maintaining high standards of product quality and safety across the development lifecycle.
- Experience in DHF Gap assessments and Remediation activities.
- Experience in Medical Device SotA standard gap assessment for EU MDR and 510k projects.
- Implemented and Maintained quality systems according to ISO 13485:2016 and ISO 9001:2015. Performed Internal Quality Audits according to ISO 13485:2016 and ISO 9001:2015.
- Should Performed risk assessments according to ISO 14971:2019.
- Experience in Planning software verification and validation activities by identifying test requirements.
- Should have Worked on Technical documents like Trace matrix, STED, Design inputs, LRS.
- Should Perform Gap assessments and remediation activities for IEC 60601-1 series, IEC 62304, IEC 62366-1, ISO 11607-1, ISO 11607-2 and other medical device standards.
- Have knowledge in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Hands on experience in labeling activities based on ISO 20417 and ISO 15223-1.
Skills Required
Verification and Validation (V&V),USFDA,Cybersecurity,Software V&V,ISO 14971 Risk Management,IEC 62304,IEC 62366,Medical Device Standards,Product Risk Management,Quality Management Systems (QMS)
Location
Bengaluru, India
Desirable Skills
Verification and Validation (V&V),USFDA,Cybersecurity,Software V&V,ISO 14971 Risk Management,IEC 62304,IEC 62366,Medical Device Standards,Product Risk Management,Quality Management Systems (QMS)
Designation
Associate
