Software Design Control Engineer
Echo Neurotechnologiesabout 2 hours ago
Base Salary
$170k - $220k/yr
Responsibilities
- Author, review, and maintain design control documentation for software products.
- Ensure compliance with IEC 62304, ISO 13485, and FDA regulations.
- Manage software risk assessments and maintain risk management files.
- Produce verification and validation protocols and reports in collaboration with engineering teams.
- Compile technical documentation for regulatory submissions.
- Update software documentation for post-market surveillance and compliance.
Requirements
- 5+ years of experience in the medical device industry with software-driven devices.
- Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, or related field.
- Experience in writing and managing formal medical device software documentation.
- Proven track record of navigating FDA clearance processes for medical device software.
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.