Johnson & Johnson MedTech · 13 hours ago
Senior Software Design Quality Engineer
Danvers, MA
Full-time
Hybrid
Mid, Senior Level
$105K/yr - $169K/yr
5+ years expJohnson & Johnson MedTech is committed to healthcare innovation, focusing on developing smarter and less invasive treatments. The Senior Software Design Quality Engineer will support new product development and play a key role in product risk management, cybersecurity, and design controls within a collaborative team environment.
Hospital & Health Care
Responsibilities
Drive 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
Lead and conduct risk management activities including development of Risk Management Plans, Hazard Analyses, Software Failure Modes and Effects Analysis (SFMEA) and Risk Management Reports
Drive assessments of 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
Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software development and testing
Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on 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
Review and approve Change Requests as needed to release software revisions to production/field
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities
Drive 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
Drive compliance of QMS through authoring and updating Standard Operating Procedures (SOP)
Qualification
Required
A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset
A minimum of 5 years of related work experience within the medical device industry on SaMD and SiMD systems
Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR
Experience with 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
Preferred
Work experience with Class III medical device capital equipment development
Experience with owning, conducting and maintaining risk management activities, including the risk management file
Experience with JAMA and Atlassian suite of tools (JIRA/Confluence)
Experience with cybersecurity within a regulated industry
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
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 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
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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