Sr. Software Quality Engineer
Echo Neurotechnologiesabout 5 hours ago
Responsibilities
- Participate in the implementation of the Quality Management System in compliance with FDA and ISO standards.
- Support the product development team in creating design history files and related documentation.
- Guide and lead risk management activities, including FMEA and hazards analysis.
- Lead computerized system assurance and validation activities for software tools.
- Engage with suppliers to support design and development activities.
- Participate in internal and external audits, providing documentation for compliance.
- Support root cause analysis for nonconformances and promote continuous improvement initiatives.
Requirements
- Bachelor’s or Master’s degree in Engineering or related field.
- 8+ years of quality engineering experience in medical device development.
- Strong understanding of medical device regulations and standards.
- Experience with software verification and validation activities.
- Hands-on experience with risk management tools and design controls.
- Ability to establish work relationships across multi-disciplinary teams.
- Experience in navigating ambiguity and thriving in fast-paced environments.
Benefits
- Opportunity to work on cutting-edge projects that transform patients’ lives.
- Competitive compensation, including stock options.
- Comprehensive benefits package.
- 401(k) program with matching contributions.