Manager, Software Design Quality Engineering
Johnson & Johnson is currently recruiting for Manager, Software Design Quality Engineering! This position will be located in Danvers, MA!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https : / / www.jnj.com / .
Position Summary :
The Software Design Quality Engineering Manager leads a team utilizing Software Design Quality Engineering, and Risk Management techniques and expertise to provide management and functional support for the entire software development life cycle (SDLC) of Abiomed's software products.
This position also supports company compliance with applicable federal, industry, and corporate procedures, guidelines, and regulations during the design, development, test, and installation of software products and the software aproducts for US and ROW.
Primary Duties and Responsibilities :
Lead Software Design Quality Engineering team in support of Abiomed's Product Development and Software Development Life Cycle processes for various medical device projects.
Including Software in Medical Device (SiMD), MDDS, CDS, IoT, Multi-function devices, and SaMD projects.
- Accountable for the Software Risk Management, Software Development Lifecycle, Design Control, and Change Control processes.
- Represent the Software Design Quality Engineering function in Notified Body and Regulatory body audits / inspections
- Design and implement process improvements for the Software Design Quality Engineering function, in areas such as design controls, change control, risk management, and software anomaly tracking.
- Define and communicate overall objectives for the Software Design Quality team.
- Manage long and short-term planning for the Software Design Quality Engineering team, including training, development, and goal setting.
- Build and maintain strong interpersonal relationships within and outside of the business unit.
- Support and ensure adherence to Abiomed's product cybersecurity processes.
- Ensure robust processes are employed in new product development.
- Provide input and leadership for Quality policies, approaches, and standard practices.
- Support maintaining alignment with US and International regulations and standards, as well as Abiomed quality systems.
- Identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), EU MDR, ISO 13485, ISO 14971, IEC 62304, etc.
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