Software Design Quality Engineer

Johnson & Johnson MedTech is dedicated to healthcare innovation, aiming to develop smarter and less invasive treatments. The Software Design Quality Engineer will support new product development and risk management activities, ensuring compliance with quality standards in medical device software.

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
• Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients
• 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
• 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)

Skills

• A minimum of a Bachelor's degree in an engineering or scientific discipline is required
• A minimum of 6 months of related work experience
• 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
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international
• Work experience in a highly regulated 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

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 Overview