Johnson & Johnson MedTech · 3 hours ago
Software Design Quality Engineer II
Danvers, MA
Full-time
Hybrid
Entry, Mid Level
$92K/yr - $148K/yr
2+ years expJohnson & Johnson MedTech is committed to healthcare innovation, developing personalized treatments at the intersection of biology and technology. The Software Design Quality Engineer II will support New Product Development and sustaining activities, focusing on product risk management, cybersecurity, and ensuring compliance with quality standards.
Hospital & Health Care
Responsibilities
Support quality focused design and development of software within the software development lifecycle (Agile/waterfall/SAFe/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability
Use Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) technical expertise, knowledge, and experience to rapidly innovate the company’s medical devices for use in chronic heart failure patients
Drive 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 and assess 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
Ensure that Design Controls are compliant with IEC 62304
Proactively participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing technical feedback of software verification and validation activities
Develop and/or review test protocols, reports, and engineering summaries
Contribute 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
Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary
Support 3rd party audits, including follow-up on actions
Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP)
Performs other duties assigned as needed
Qualification
Required
A minimum of a Bachelor's degree in an engineering or scientific discipline is required
A minimum of 2 years of related work experience
Intermediate knowledge of quality system regulation, including 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR
Intermediate knowledge of Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) systems
Intermediate knowledge of software development lifecycle processes (waterfall, agile, and DevOps) as applied within the regulated medical device industry
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and internationally
Preferred
Work experience in a highly regulated industry
Experience conducting Hazard Analysis and Software Failure Mode Effects and Analysis
Design control and/or new product development experience
Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)
Experience with cybersecurity within a regulated industry
Benefits
Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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