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.

Software Design Quality Engineer

Job Description

Required Skills