Senior Software Systems Engineer Neuromodulation Pelvic Health Pre-Market Design Quality
Overview
Lead design quality support for software and medical device development ensuring compliance with design controls and regulatory standards. Drive verification and validation strategies while mentoring engineers and collaborating across cross-functional teams.
What You'll Do11
- 1Provide design quality support for software and medical device development from concept to manufacturing transfer
- 2Ensure compliance with design control and risk management requirements
- 3Review system requirements and architecture documentation
- 4Support verification and validation strategies for software and integration testing
- 5Partner with engineering and regulatory teams to resolve design quality issues
- 6Evaluate deliverables for completeness and regulatory readiness
- 7Conduct hazard analysis and software risk evaluation activities
- 8Participate in design reviews and provide constructive feedback
- 9Assist in root cause analysis and corrective actions for quality issues
- 10Mentor engineers on design quality practices and compliance
- 11Contribute to continuous improvement of design quality processes
Requirements11
- 1Bachelor's degree in Software Engineering or related field with 4+ years experience
- 2Master's degree with 2+ years relevant experience or PhD
- 3Demonstrated experience with design controls and verification/validation
- 4Strong understanding of IEC 62304 and ISO 14971 standards
- 5Experience with agile development and quality practices
- 6Familiarity with medical device industry regulations
- 7Knowledge of FDA design control expectations
- 8Advanced degree preferred in engineering or related discipline
- 9Baccalaureate degrees from outside US require 8 CFR 214.2(h)(4)(iii)(A) compliance
- 10Physical mobility required for office role
- 11U.S. work authorization required for principal level positions
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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