- Company Name
- Natus Medical Incorporated
- Job Title
- Senior Systems Engineer
- Job Description
-
Job Title: Senior Systems Engineer
Role Summary
Senior Systems Engineer responsible for risk management, design control, usability engineering, and compliance of medical electrical systems in neurology. Engages throughout product lifecycle for new introductions and maintenance, ensuring adherence to ISO 13485, ISO 14971, 21 CFR 820, EU MDR, and related standards.
Expectations
- Execute end‑to‑end risk analysis (FTA, FMEA).
- Maintain risk‑control traceability to product requirements, verification, and validation.
- Coordinate cross‑functional activities: regulatory, quality, clinical, marketing, engineering.
- Contribute to product line engineering and platform harmonization.
- Support quality improvement, complaints investigation, change control, and safety assessment.
- Travel up to 25% domestic or international.
Key Responsibilities
- Lead risk analysis activities and apply risk‑management tools.
- Analyze production and post‑market data to refine risk controls.
- Develop and update design controls procedures for legacy and new products.
- Maintain traceability between risk controls, requirements, and verification/validation.
- Collaborate with regulatory, quality affairs, clinical, marketing, and engineering stakeholders.
- Participate in CAPA, DHF, quality improvement, complaints, change control, and safety assessment processes.
- Drive convergence of system architecture and reusable components across platforms.
- Communicate findings and recommendations to senior risk management and engineering leadership.
Required Skills
- Strong risk‑management expertise (FTA, FMEA, risk‑control implementation).
- Proficiency with design controls, verification/validation traceability, CAPA, DHF.
- Knowledge of ISO 13485, ISO 14971, US FDA QSR (21 CFR 820), EU MDR.
- Ability to manage multiple concurrent projects in a fast‑paced, ambiguous environment.
- Effective cross‑functional communication and coordination.
- Project management skills (facilitating meetings, tracking deliverables).
- Exposure to EEG/EMG medical device domains is advantageous.
Required Education & Certifications
- Bachelor’s degree in Engineering or Science (Master’s preferred).
- Minimum 4 years of systems engineering experience; 5+ years in medical device industry.
- Demonstrated experience with regulatory standards and quality systems.