Principal Software Quality Engineer

Mainstay Medical

Mainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The company is headquartered in Dublin, Ireland, with subsidiaries operating in the United States, Australia, the United Kingdom, and Germany.

The Role:

The Principal Software Quality Engineer is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle (SDLC) for new and sustaining product development initiatives for Mainstay Medical’s Class III products and Software as a Medical Device (SaMD). This includes ensuring that the software development process and products are compliant with applicable standards, regulations and guidance documents, and continuously improving the design control and postmarket process to the evolving software regulatory environment, including cybersecurity and software risk management. This individual serves as the subject matter expert on software quality engineering, partnering and collaborating with cross-functional team members in Product Development, Regulatory Affairs, Clinical, Operations, and IT. The ideal candidate has a strong background in software development and verification/validation (V&V), paired with deep knowledge of digital health and medical device regulations.

Position Responsibilities: 

• Lead Design Control and Software Development Quality projects and initiatives to ensure appropriate Design History File documents for Class III medical devices, mobile medical applications (MMAs), cloud-based systems, and cybersecurity controls. This includes providing timely guidance and expertise during creation and review of software development artifacts such as software requirements, architecture, design documentation, risk management, planning documentation, V&V protocols/reports, and release notes; and evaluating design updates and impact assessments for software updates.
• Ensure software development and maintenance comply with regulatory standards including FDA revised 21 CFR Part 820 (QMSR), ISO 13485, IEC 62304/82304, ISO 14971, and IEC 62366, and other applicable guidances related to software, firmware, and software as a Medical Device (SaMD).
• Support creation of necessary documentation to comply with regulatory requirements and industry best practices, including creation and maintenance of Software Development Lifecycle (SDLC) procedures and work instructions.
• Ensure design control deliverables meet regulatory expectations for premarket submissions and audits and support creation of necessary documentation to comply with regulatory requirements and industry best practices. Support efforts for cybersecurity and security risk management for both US and global requirements, as applicable where product is commercialized.
• Support internal and external audits, including FDA inspections and notified body ISO audits.
• Support and contribute to execution of risk management activities in compliance with ISO14971 and software risk requirements in IEC 62304.
• Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.
• Provide guidance on and participate in software development activities including design and code reviews, risk reviews, requirements analysis and tracing, defect tracking and investigation, and configuration management.
• Perform quality supplier management and support of software contractors, as required.

Qualifications:

• B.S. degree in engineering/scientific/computer systems, or related field.
• ASQ, CSQE or other software quality certificates are beneficial.
• A minimum of 8 years work experience in Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• A minimum of 5 years experience with medical device software development, including software mobile medical applications (MMAs), firmware, cloud-based systems, and cybersecurity.
• Experience in the development and implementation of effective Design Control Systems, including working knowledge of QMSR (revised FDA 21 CFR Part 820) and ISO 13485 quality system standards, and SDLC per IEC 62304.
• Working knowledge of data privacy requirements in U.S. and EU (GDPR) desired.
• Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and premarket regulatory submission requirements.
• Strong knowledge of risk management and usability engineering standards (ISO 14971, IEC 62366).
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Excellent communication, technical writing, and cross-team collaboration skills.
• Experience coordinating or leading audits beneficial.

The salary range for this position is $134,000 to $159,000/year; however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.

Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.