Senior Software Design Quality Engineer (Medical Devices SaMD)

• Provide software quality oversight throughout the medical device software lifecycle, from requirements and architecture through verification, validation, release, and post-market activities.
• Ensure software development activities comply with applicable medical device regulations, standards, procedures, and design controls.
• Apply and interpret IEC 62304, ISO 14971, ISO 13485, FDA 21 CFR Part 820/QMSR, and applicable FDA software guidance.
• Support software quality activities for SaMD, embedded software, connected medical devices, wearable devices, and/or cloud/mobile components associated with medical devices.
• Review and approve software development and quality documentation, including:
• Software Development Plans
• Software Requirements Specifications (SRS)
• Software Architecture and Design Documentation
• Software Risk Assessments
• Software FMEA / DFMEA
• Hazard Analysis and Risk Management Files
• Software Verification & Validation Plans and Protocols
• Test Cases, Test Results, and Reports
• Traceability documentation
• Software Release and Change Control documentation
• Work with Software Engineering and Systems Engineering to ensure user needs * system requirements * software requirements * implementation * verification/validation are appropriately linked and documented.
• Participate in medical device software risk management, including identification of software-related hazards, hazardous situations, failure modes, causes, risk controls, and verification of risk-control effectiveness.
• Review software verification and validation strategies, test protocols, test cases, results, deviations, anomalies, and defect assessments.
• Evaluate software development processes and records for compliance with internal procedures and applicable regulatory requirements.
• Support software-related CAPA, nonconformance, complaint, change control, and defect investigation activities.
• Support cybersecurity activities for medical device software, including review of cybersecurity-related risks, controls, requirements, verification, and documentation.
• Collaborate with R&D, Software Engineering, Systems Engineering, Product Quality, Regulatory Affairs, Clinical, Manufacturing, and other cross-functional teams.
• Support regulatory submissions and remediation activities involving medical device software, including 510(k), PMA, EU MDR, and other international submissions, as applicable.
• Participate in internal audits, supplier assessments, FDA inspections, Notified Body audits, and MDSAP activities related to software quality.
• Review software and computerized systems used in manufacturing, testing, service, and product support from a regulated quality perspective.
• Support design transfer and product lifecycle activities to ensure appropriate software and system quality controls are maintained through production and post-market phases.
• Analyze software quality data, defects, trends, and recurring issues and support continuous improvement activities.

We are looking for multiple Senior Software Quality Engineer with hands-on medical device industry experience to support the development and lifecycle management of regulated medical device software, SaMD, connected devices, and wearable medical products.

This is not a general software QA, SaaS QA, or IT software quality position. Candidates must have direct experience working in a regulated medical device environment and applying medical-device software quality, design controls, risk management, and verification/validation requirements.

The ideal candidate has worked closely with Software Engineering/R&D, Systems Engineering, Quality, Regulatory, and Risk Management teams and understands how software development activities integrate with the medical device product development process., Candidates should have direct hands-on experience in medical device product development or quality engineering, preferably involving Class II or Class III products., * 5+ years of experience in software quality engineering within the medical device industry

• Direct experience applying IEC 62304 to medical device software
• Hands-on experience with ISO 14971 medical device risk management
• Experience with medical device design controls and software lifecycle documentation
• Experience reviewing or approving medical device software requirements, architecture/design, risk documentation, and V&V documentation
• Experience with software verification and validation in a regulated medical device environment
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820/QMSR
• Experience working with Software Engineering/R&D teams on regulated medical device products
• Understanding of the relationship between software requirements, system requirements, risk controls, and verification/validation
• Experience supporting regulatory or quality activities for commercial or pre-market medical device products

Preference will be given to candidates with experience in one or more of the following:

• Software as a Medical Device (SaMD)
• Wearable medical devices
• Connected medical devices
• Embedded medical device software
• Cloud-connected medical devices
• Mobile medical applications
• Electromechanical medical devices with embedded software
• Class II/III medical devices
• Combination products with significant software components

Additional Preferred Experience

• Medical device cybersecurity and FDA cybersecurity expectations
• FDA 510(k) or PMA submissions involving software
• EU MDR technical documentation involving medical device software
• AAMI TIR57/TIR97 or related medical device cybersecurity practices
• Software FMEA / DFMEA and software-related hazard analysis
• Traceability and requirements management
• Software anomaly/defect investigation
• Medical device CAPA and nonconformance investigations
• Experience interacting with FDA, Notified Bodies, or MDSAP auditors
• Experience with regulated computerized systems used in manufacturing, laboratories, quality, or product support
• ASQ CSQE, RAC, or related quality/regulatory certification

Education

• Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, Electrical Engineering, Systems Engineering, or a related technical discipline
• Master’s degree is a plus