Job Mission:
To ensure product design and development activities comply with ISO 13485 design control requirements and ISO 14971 risk management standards, maintaining regulatory compliance, product safety, and documentation integrity across the product lifecycle while supporting continuous improvement within the Design and Development function.
Accountabilities:
Product Lifecycle Management and Market Surveillance - Completion of formal product review cycle every 2 years covering complaints, CAPAs, audits and feedback. Monitor complaint and post-market surveillance trends to identify systemic risks and escalate potential regulatory issues.
Design File Compliance - 100% of existing product design files reviewed and updated to meet latest internal SOPs and regulatory requirements within the first 12 months. DHF completeness maintained above 95% and audit-ready.
Engineering Change Control - Engineering Change Requests (ECRs) and Engineering Change Orders (ECOs) managed and documented in accordance with change control procedures
Risk Management and Post-Production Monitoring - Participation in product risk reviews and post-production monitoring activities aligned with ISO 14971
Audit and Regulatory Compliance - Zero major non-conformances attributable to design documentation during ISO 13485 surveillance or recertification audits
Corrective Action and Quality Improvement - Support investigation and closure of design-related CAPAs and non-conformances within agreed quality system timelines
Responsibilities:
Product Compliance and Regulatory Alignment
- Ensure product design and development documentation complies with ISO 13485 design control requirements and regulatory expectations.
- Review and maintain Design History Files (DHF) and technical documentation to ensure completeness, traceability and alignment with current internal SOPs and quality standards.
- Support the Head of Design and Development in maintaining compliance of design processes within the Quality Management System.
- Maintain traceability between design inputs, design outputs, verification, validation, and risk management documentation in accordance with ISO 13485 design control requirements.
- Compile information required for registration of new products to Regulatory Authorities, meeting requirements of EU MDR (CE), FDA, TGA etc
Product Lifecycle and Market Surveillance
- Support lifecycle management activities including structured product reviews, complaint analysis, CAPA feedback integration and audit findings.
- Conduct formal product review cycles every two years to ensure product files remain compliant with regulatory and internal requirements.
- Monitor post-production information including complaints, field feedback and audit results to identify improvement opportunities.
- Monitor updates to applicable medical device standards, regulatory requirements, and industry guidance to identify potential impacts on product compliance.
- Provide technical support for regulatory documentation and product registrations where required.
Engineering Change Management
- Own the Engineering Change Request (ECR) process, ensuring all design changes are assessed for regulatory, risk management, and design control impacts in accordance with ISO 13485.
- Review and approve Engineering Change Orders (ECOs) to ensure design documentation, risk files, and regulatory records remain compliant.
- Collaborate with the Manufacturing Engineer to ensure approved design changes are implemented correctly within production.
Risk Management
- Maintain and update product risk management files in accordance with ISO 14971, ensuring hazards, risk controls, and post-production monitoring activities remain current.
- Support risk assessments, hazard analysis and risk control documentation throughout the product lifecycle.
- Assist with post-production monitoring and feedback loops to ensure risk controls remain effective.
Quality and Continuous Improvement
- Support internal audits, non-conformance investigations and corrective action activities.
- Collaborate with Quality and Engineering teams to identify root causes and support quality improvement initiatives.
- Ensure technical records and compliance documentation remain audit-ready.
- Support preparation for ISO 13485 surveillance and recertification audits by ensuring design documentation and technical records are maintained in an audit-ready condition.
Competitive and Regulatory Intelligence
- Conduct competitor product reviews and analysis using industry databases such as FDA MAUDE and EUDAMED.
- Monitor industry developments, regulatory changes and emerging safety signals that may affect product compliance.
Cross-Functional Collaboration
- Work collaboratively with Engineering, Quality and Manufacturing teams to ensure design compliance and effective implementation of changes.
- Provide compliance guidance during design reviews and product development discussions.
- Collaborate with the Manufacturing Engineer to ensure manufacturing implementation of design changes remains compliant with design control and risk management requirements.
Qualifications and Experience:
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Product Design Engineering, or a related discipline (preferred).
Required Knowledge
- ISO 13485 design control requirements.
- ISO 14971 medical device risk management.
- ISO 14971 medical device risk management. Understanding of regulated product environments, preferably medical devices.
- Product lifecycle management and engineering change control processes.
Required Skills
- Strong technical documentation and compliance review capability.
- Ability to analyse design records and identify compliance gaps.
- CAD capability with preference for SolidWorks.
- Strong cross-functional collaboration and communication skills.
Required Experience
- Experience working in Class I medical device design and development.
- Experience working within a regulated product development environment.
- Experience supporting design documentation, risk management or quality system activities.
