What are the responsibilities and job description for the Sr. Principal Software Quality Engineer position at DivIHN Integration Inc?
For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Meghna at 224 369 4230
Meghna at 224 369 4230
Title Sr. Principal Software Quality Engineer
Duration 12 Months (Temp to hire)
Location - Bellevue, WA
Duration 12 Months (Temp to hire)
Location - Bellevue, WA
Hybrid candidate will be working with engineers and will need to come to the office on a regular basis.
Job Description :
Essential Duties and Responsibilities:
Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software. Responsible for quality oversight and approval of software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures.
Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment.
Support/lead non-product software assessments and qualification efforts.
Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Follow documented procedures for all activities related to the Company's Quality System.
Support other areas of the Quality System and perform other tasks as defined by Management.
Complete other duties as assigned.
Partner with development teams and cross-functional stakeholders to provide technical and strategic feedback associated with the development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, AI/ML algorithms and cybersecurity aligned with applicable regulations, standards, and business needs.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated design control documentation for medical device software. Responsible for quality oversight and approval of software product development plans, risk management, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Lead activities for establishing, implementing, and maintaining medical device software Risk Management Files (RMF), including analyzing and evaluating risks, controlling identified risks, and monitoring the effectiveness of the risk control measures.
Establish and cultivate positive relationships with cross-functional stakeholders and product development team members to optimize the success of development projects.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production/field deployment.
Support/lead non-product software assessments and qualification efforts.
Lead changes to the Quality System based on new regulations, mentorship documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Follow documented procedures for all activities related to the Company's Quality System.
Support other areas of the Quality System and perform other tasks as defined by Management.
Complete other duties as assigned.
Qualifications:
Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms.
Experience leading activities for establishing, implementing, and maintaining medical device software Risk Management Files.
Experience supporting the development of design control and design history file documentation for medical device software from inception through successful Design Transfer.
Experience supporting software development teams using Agile development methodologies including supporting iteration planning, execution, demonstrations, and retrospective activities.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Strong solid understanding of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, AAMI TIR57, IEC 60601 series, IEC 62366.
Solid understanding of Secure Product Development Framework (SPDF), including security risk management per AAMI TIR57, creation and maintenance of sBOMs, security architecture, security testing, transparency, and post-market vulnerability management.
Strong verbal and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.
Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
Ability to manage numerous projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Organized self-starter, able to work in a fast-paced environment.
Ability to work independently and as part of team, strong collaborative skills.
Ability to manage competing priorities and "wear many hats."
Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
Proficient in Microsoft Office, Azure DevOps, Adobe Acrobat, statistical analysis (e.g., Minitab), vulnerability scanning, and other business software.
Ability to perform duties and responsibilities remotely or on-site.
Solid understanding of artificial intelligence and SaMD preferred.
Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
Experience working within an AAMI TIR45 framework for the development of SaMD preferred.
Experience supporting development of cloud-based software and deep understanding of cloud infrastructure preferred.
Experience in security risk management and ISO/IEC 27001 preferred.
Experience supporting development of medical device software (SaMD and SiMD), digital health products, cloud-based systems, and AI/ML algorithms.
Experience leading activities for establishing, implementing, and maintaining medical device software Risk Management Files.
Experience supporting the development of design control and design history file documentation for medical device software from inception through successful Design Transfer.
Experience supporting software development teams using Agile development methodologies including supporting iteration planning, execution, demonstrations, and retrospective activities.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Strong solid understanding of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971, AAMI TIR57, IEC 60601 series, IEC 62366.
Solid understanding of Secure Product Development Framework (SPDF), including security risk management per AAMI TIR57, creation and maintenance of sBOMs, security architecture, security testing, transparency, and post-market vulnerability management.
Strong verbal and written communication and presentation skills. Demonstrated interpersonal skills including strong negotiation skills.
Excellent writing skills to develop clear and logical information and conclusions based on design documentation.
Ability to manage numerous projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Organized self-starter, able to work in a fast-paced environment.
Ability to work independently and as part of team, strong collaborative skills.
Ability to manage competing priorities and "wear many hats."
Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
Proficient in Microsoft Office, Azure DevOps, Adobe Acrobat, statistical analysis (e.g., Minitab), vulnerability scanning, and other business software.
Ability to perform duties and responsibilities remotely or on-site.
Solid understanding of artificial intelligence and SaMD preferred.
Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
Experience working within an AAMI TIR45 framework for the development of SaMD preferred.
Experience supporting development of cloud-based software and deep understanding of cloud infrastructure preferred.
Experience in security risk management and ISO/IEC 27001 preferred.
Education and Experience:
B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
Minimum of eight (8) plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development
B.S./M.S. in relevant engineering field (e.g., biomedical, computer science, software, electrical, etc.) or equivalent scientific degree.
Minimum of eight (8) plus years of progressive Quality Engineering experience in the medical device industry with hands-on support for software development
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
