Johnson & Johnson is looking to solve complex diseases by developing smarter, less invasive, and more personalized treatments through innovation at the intersection of biology and technology. The Software Design Quality Engineer will support new product development and sustaining activities for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products to achieve these goals.
Requirements
- Knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR.
- Knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems.
- Knowledge of software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry.
- Experience conducting Software Failure Mode Effects and Analysis
- Design control or new product development experience
- Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)
- Experience with cybersecurity within a regulated industry.
Responsibilities
- Support design and development activities within the software development lifecycle for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) products.
- Facilitate and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports.
- Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include but are not limited to software detailed designs, software architecture and specifications.
- Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback of software verification and validation deliverables.
- Develop and/or review test protocols, reports, and engineering summaries
- Participate in product cybersecurity activities including product security planning, threat analysis, cybersecurity risk assessments, periodic monitoring and reporting.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
Other
- A minimum of a Bachelor's degree in an engineering or scientific discipline is required.
- A minimum of 6 months of related work experience.
- Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international.
- This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week and will require 10% of domestic and/or international travel.
- This position will require to work hybrid in Danvers, MA with a minimum of 3 days per week
