Senior Systems Engineer - Risk Management
Natus Medical
- Hyderabad, Telangana
- Permanent
- Full-time
- Create, maintain, and revise risk management files for medical diagnostic equipment
- Write and review risk assessment documentation for CAPAs, NCRs, and FCAs
- Support post-market surveillance risk assessments
- Review and provide input into process and design FMEA documents
- Interface with human factors engineering to document and mitigate user risks
- Develop user and product requirements and specifications for medical devices, software, and systems using a deep understanding of requirements development principles.
- Contribute to traceability between design inputs, design outputs, risk management files, and verification and validation
- Participate in or lead technical design reviews, quality improvements, complaints investigation, change control, and safety assessment processes
- Apply ISO 13485, ISO 14971, US FDA Quality System Regulations (21 CFR 820), EU MDR and relevant international standards to design activities.
- Coordinate activities with contributors from regulatory and quality affairs, clinical, marketing, and cross-functional engineering disciplines.
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers
- Understand, apply, and contribute to the development of quality management system and design controls processes.
- Identify improvement opportunities for the risk management function and deliverables
- Bachelor's degree in Engineering or Science, Master's degree is an asset
- Minimum 5 years experience in medical device design and development.
- Demonstrated ability to work within a fast-paced environment, high levels of ambiguity, multiple concurent projects, and conflicting assignments.
- Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
- Knowledge of medical device technology, applicable quality and safety standards, and regulations
- Knowledge and experience with medical device risk management (ISO 14971)
- Knowledge of information technology: PCs, servers, software, and databases.
- Knowledge of product lifecycle management.
- Experience with requirements specification and traceability, FMEA, risk/hazard analysis