Software Quality Engineer – Principal thinks “outside the box” in the implementation of the Software Design Control and SDLC (software development lifecycle) programs providing Quality Assurance and Regulatory oversight and ensuring compliance with all applicable regulations and incorporations of software industry best practices. 

This candidate can work in a 100% remote capacity and must be located in the US.

• This position is responsible for leading Quality Assurance and software regulatory activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of product development and Quality Systems.
• This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials
• This role will interface with other cross-functional teams (e.g. Research and Development, Enterprise IT Dev Ops, Operations, Bioinformatics, Clinical Services, Diagnostics services, Laboratory Operations, Manufacturing, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, software used for automation of the IVD products, and Quality management systems
• Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity
• Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) and ssPMA Submission
• Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements
• Plan for the Verification and Validation of the system requirements and user needs for the integrated system
• Support team through the process of gathering customer needs from different stakeholders, translate them into system design, system requirements, and sub-system requirements that form the basis of system validation ensure sub-systems maintain performance when integrated
• Support development teams on the validation of software development tools
• Provide guidance for the generation, review and approval of design control documentation with primary focus on software development deliverables
• Collaborate with research and development and automation to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes
• Serve as the Software Design Control expert to various Medical Device development projects across the organization
• Develop and deliver Design Control training for the software development, Bioinformatics, IT, Research and development, and other functions
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback
• Support the creation of necessary documentation to comply with regulatory requirements and industry best practices
• Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304
• Own the Risk Analysis process to meet ISO 14791 requirements, including Hazard Analysis, FMEA, management and tracing of risk controls, and planning and tracing of verification and validation of risks
• 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, requirements analysis and tracing, defect tracking and configuration management
• Drive and continuously improve our Quality Management System Regulation (QMSR) to ensure all design and development activity is fully compliant with global medical device regulations and standards.

QUALIFICATIONS

Required Work Experience: 

• BS degree, in an engineering/scientific/computer system/ or quality management curriculum or equivalent experience. 
• A minimum of 8-10 years’ work experience in Software Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• Experience with Hazard Analysis (HA), and Failure Mode and Effect Analysis (FMEA)
• Experience with medical device software development.
• Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.
• Experience with software mobile applications, cloud-based systems, and cybersecurity.
• Experience in the development and implementation of effective Design Control Systems.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
• Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for ssPMAs, and 510(k).

Preferred Work Experience: 

• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Physical and Mental Requirements:

• Capability to move around the lab space and various environments including warehouse, laboratory, office.
• Strong attention to detail for thorough analysis of quality data and documentation.
• Excellent problem-solving skits to identify and address quality issues effectively.
• Ability to work under pressure and meet deadlines, maintaining accuracy.
• Strong communication skills to collaborate with various teams and present finding effectively.

Knowledge: 

• Working knowledge of ISO 14971 and/or experience in conducting risk management activities, e.g. hazard analyses, and FMEA
• Experience in the development of system architectures
• Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.
• Experience with electronic Quality Management Systems 
• Software validation practices, methodologies, and techniques, preferably in validating medical devices.
• Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.
• Experience in leading internal/External audits and regulatory inspections.

Skills: 

• Effective verbal and written communication skills
• Experience collaborating and communicating with individuals at multiple levels in an organization.
• Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
• Strong analytical and problem-solving skills.
• Able to work effectively in a high-stress, high-energy environment.
• Ability to influence people and projects in a fast-moving environment.

EDUCATION
Bachelor’s Degree(Required)

LICENSECERTIFICATIONS
Quality Engineer (CQE)
Six Sigma Certified Black Belt
Six Sigma Certified Green Belt

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.