Sr. Software Design Assurance Engineer

Reports to Sr. Director, Advanced Development and Software Engineering

Role Summary

This role will be responsible for ensuring the new software products and design changes to existing software meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.  This will be accomplished through close collaboration with cross-functional teams.  The Software Design Assurance Engineer participates in all phases of the software development process.  This includes development, debugging, design controls, input requirements, early testing and verification and validation, process development activities, product risk management requirements, product reliability activities, and delivery.

Essential Responsibilities

• Has a focus on embedded software, cloud software, machine-learning algorithms, and software usability
• Participate in the design control and review processes, including project planning, quality planning, and phase reviews
• Review requirements, specifications, and technical design documents to provide timely feedback
• Draft and review design control deliverables for software development or design/process changes
• Actively participate in risk analysis development including FMEAs, hazard analysis, and other risk management file requirements
• Responsible for the review and approval of design and verification and validation protocols and test reports
• Review and assist the development of regression testing plans
• Lead and support root cause investigations and actions for issues arising from design or process verification and validation activities
• Stay up to date with new quality and regulatory requirements, and drive process and procedure updates as needed
• Responsible for compliance of in-house requirements and best practices regarding software
• In collaboration with regulatory affairs, assume responsibility for compliance with regulatory requirements
• Provide quality and compliance support during regulatory audits and responses to government agency questions
• Assist CAPA efforts, and apply systematic root cause problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues
• Manage the work of a direct report, e.g., Software Testing Engineer
• Other duties as assigned

Experience & Qualifications

Must Have

• A minimum of 5 years experience in software design assurance
• A bachelor’s degree in science, engineering, or other related technical discipline or equivalent work experience
• Experience in medical device software design assurance
• Experience in design verification and transfer to manufacturing activities
• Experience in development of requirements and test planning for design validation and usability
• Experience with medical software verification and validation for global market regulatory requirements
• Understanding of medical device design controls and risk management regulations such as ISO 13485, FDA 21 CFR 820.30, MDR (EU) 2017/745, ISO 14971, 60601, 62366, 62304, and other relevant product standards
• Knowledge of US and International regulations, such as 21 CFR Parts 820, 210, 211, and 11 and other relevant regulations

Preferred

• Experience in medical imaging or electro-mechanical medical devices
• ASQ Certified Quality Engineer (CQE)
• Experience Minitab Statistical Analysis software (or equivalent)
• Experience with Artificial Intelligence in a medical device setting
• Experience with one or more of the major public cloud computing platforms (e.g., AWS, Azure, GCP)

Does this look like a good fit?

We’re actively growing our team in Bedford, MA, and would love to hear from you.