Senior Engineer, Device Development Quality

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Job DescriptionLead Quality Engineering guidance and oversight for Software as a Medical Device (SaMD) products during, all phases of design control, risk management, human factor/usability engineering, design & development and verification/validation testing, as well as lifecycle management during design changes.Work with the device development team to define critical to quality characteristics for device components and finished devices.Lead Quality review and approval of all technical documentation for design and development, technical and risk management documentation, e.g., software development plan, software requirements specification, software architecture and design, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements.Represent Device Quality on cross-functional teams in support of SDLC activitiesReview and approve software system deliverables/releases and related documentation such as instructions, software standards and software guidelines.Provide input to design transfer, software maintenance and deployment activities to ensure compliant, robust product realization.Support post-market surveillance activities such as change management, product complaint handling, and Deviations/CAPAsSupport Product Team and strategy for filing and implementing changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions, and/or leading the Quality subteam.Lead or support sustainable, continuous improvement to the digital device product Quality Management System and best practices for device lifecycle processes by identifying areas for improvement and engaging in remediation. Function as the Quality representative on cross-function initiatives and device development programs.Manage QA interface with medical device or device component suppliers and testing partner by providing technical and quality support during the development, testing and manufacture at a supplier site. Prepare and manage development quality agreements.Support internal and external audits and inspections as a software device quality Subject Matter Expert.QualificationsA minimum of 6-8 years of working experience in medical device function within a medical device, biotech, or pharmaceutical companyMinimum of a BS in Software Engineering, Information Systems or related technical or scientific disciple.Experience in software medical device design and development technical oversight and related risk assessment and management throughout the product lifecycleQuality oversight experience of software device product processes and/or computer system validation and documentationWorking knowledge and application of device regulations, including 21 CFR Part 820, ISO 13485, ISO 14971 and IEC 62304. Also, the EU Medical Device Regulation is a Plus.Experience in supplier management and relations, including quality agreement generation and maintenanceExperience in hazard analysis and application of risk analysis tools such as FMEA, Fishbone, etc.Experience with regulatory inspections and interaction with regulatory authoritiesExperience in Change Control and CAPA applicationsExperience with Software tools: HP ALM VERA, Trackwise is a plusA passion for product development and the patients who we serveStrong verbal and written communication skillsAbility to work both independently with minimal direction and within project teams to attain group goals and key project milestones.Additional InformationThis is a senior level position that is responsible for the software quality oversight of design control and risk management activities for digital products and medical devices. Independently provide verification & validation support of Software as Medical Device. This individual will work closely with the device development teams and medical device suppliers and testing partners during the device design/development phases with supportive responsibilities throughout the device lifecycle. In addition, this role will provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for software medical devices products.Videos To Watch