Manager, Software Design Quality Engineering
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About The Position
Johnson & Johnson is currently recruiting for the position of Manager, Software Design Quality Engineering, located in Danvers, MA. In this role, the Software Design Quality Engineering Manager will lead a team that utilizes Software Design Quality Engineering and Risk Management techniques to provide management and functional support for the entire software development life cycle (SDLC) of Abiomed's software products. The position is critical in ensuring compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, testing, and installation of software products for both the US and the Rest of the World (ROW). The Software Design Quality Engineering Manager will be responsible for leading the Software Design Quality Engineering team in support of Abiomed's Product Development and Software Development Life Cycle processes for various medical device projects. This includes Software in Medical Device (SiMD), Medical Device Data Systems (MDDS), Clinical Decision Support (CDS), Internet of Things (IoT), Multi-function devices, and Software as a Medical Device (SaMD) projects. The manager will be accountable for the Software Risk Management, Software Development Lifecycle, Design Control, and Change Control processes, ensuring that robust processes are employed in new product development. In addition to leading the team, the manager will represent the Software Design Quality Engineering function during Notified Body and Regulatory body audits and inspections. They will also be tasked with designing and implementing process improvements for the Software Design Quality Engineering function, focusing on areas such as design controls, change control, risk management, and software anomaly tracking. The manager will define and communicate overall objectives for the Software Design Quality team, manage long and short-term planning, and support the adherence to Abiomed's product cybersecurity processes. Furthermore, the role requires maintaining alignment with US and International regulations and standards, as well as identifying opportunities to proactively assure compliance with all applicable internal, domestic, and international quality regulations, including US 21 CFR 820 (QSR), EU MDR, ISO 13485, ISO 14971, and IEC 62304.
