Quality Engineer II

A Day in the Life This position is for quality engineering support with Medical device industry experience of strong expertise in Design History File (DHF) remediation and Risk Management activities to support compliance, audit readiness and product quality improvements. The role involves reviewing legacy design documentation, ensuring alignment with regulatory standards (ISO 13485, 21 CFR part 820, EU MDR 2017/745), process & procedures and strengthening risk management practices (ISO 14971) across product lifecycles.

• Ensure legacy design documentation is accurately migrated and aligned with current Medtronic templates and standards
• Ensure DHF & risk management files alignment with design control requirements and internal quality procedures.
• Review, assess, and remediate legacy DHFs (including risk management files) to ensure completeness and compliance with regulatory requirements (e. g. FDA, EU MDR).
• Participate with cross-functional teams to review DHF files & technical files, identify gaps & drive remediation with respect to standards such as FDA 21 CFR 820, ISO 13485, ISO 14971 and EU MDR.
• Revise or create documentation related to design controls, risk management, verification and validation, design reviews and change management.
• Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
• Identify gaps in design documentation including requirements, verification/validation, traceability and design reviews.
• Develop product risk management file (risk management plan, risk assessments, DFMEA and risk management report) as per ISO 14971 standard and internal procedures.
• Ensure complete bidirectional traceability from user needs through design inputs, outputs, V&V, and risk controls.
• Establish clear traceability between hazards, harms, hazardous situations, and mitigations in risk management files.
• Deep understanding of Change Development Process and structured change management systems.
• Comfortable working with international cross functional teams in different time zones.

• B E or B. Tech in Mechanical/Biomedical engineering
• Minimum 3-5 years of quality engineering experience or equivalence and overall 5-8 years of experience.
• DHF Remediation, Risk Remediation, Gap analysis.
• Previous experience working in a cross-functional team environment and remediation activities.
• Good verbal and written communication skills including protocol / report development and technical presentations.
• Strong in design and development, verification and validation and risk management.
• Good interpersonal skills and ability to work in a fast-paced environment.
  Nice to have:
• ISO 13485 Internal Auditor / Lead Auditor Certification.
• Experience in Test Method Validation (TMV) including statistical justification and GR&R.
• Strong understanding of statistical tools for validation and sampling rationale.