Design Quality Engineer

Own Risk Management File/RSL per ISO 14971 with full traceability to design and verification.

Lead cross-functional risk reviews; ensure risk controls are implemented, verified, and validated within DHF/Technical File.

Develop Regulatory Compliance Declarations (RCDs) for EU MDR/IVDR, FDA, UKCA aligned to IEC 60601, IEC 62304, IEC 62366-1, IEC 60601-1-2.

Manage standards compliance strategy, gap assessments, safety/EMC/software/usability testing, and audit NC closure.

Perform component & supplier compliance (COTS/SOUP, safety, EMC, biocompatibility, RoHS/REACH, cybersecurity); maintain CoC/CoA and approvals.

Author regulatory technical documentation (RMF, GSPR/ER mapping, labeling/IFU, clinical links) supporting CE/FDA approvals.

Support V&V, change control, and CAPA, assessing impact on risk, standards, testing, and regulatory filings.

Bachelor’s degree in Mechanical Engineering or related field.

5+ years’ experience in Design/Development Quality in the medical device industry.

Strong understanding of ISO 13485, ISO 14971, EU MDR, and FDA QSR.

Experience in DHF review, risk management, and design control compliance.

Excellent analytical, problem-solving, and communication skills.