Responsibilities, Skills & Hands-On Experience:

• Lead as a quality core team member responsible for driving quality into the design and development of software solutions.
• Lead quality focused design and development of software within the software development lifecycle (Agile/Waterfall/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability.
• Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports and defects.
• Lead and conduct risk management activities including system risk analysis and software FMEA’s.
• Participate in both internal and external regulatory audits and inspections.
• Manage compliance to standards for software quality operating methods, processes, and procedures (such as ISO 13485, IEC 62304, AAMI TIR 45, Security Standards, and Data Privacy).

Education & Work Experience:

• Bachelor’s degree in Engineering, Science or Technical Field with a minimum of 8+ years of experience in Engineering and/or Quality.
• Experience with software quality engineering activities for new product development.
• Ability to author technical reports, and standard operating procedures.
• Exposure to medical imaging solutions leveraging machine learning/ artificial intelligence (AI).
• Demonstrated ability to support multiple projects.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $150,000 - $200,000 + equity + benefits.