DEKA Research & Development is looking for a technically deep process-driven Software Quality Assurance Engineer to join our cloud engineering team. This is an individual contributor role with outsized organizational impact: you will work alongside cloud-native engineering teams to learn how they work codify documentation best practices and scale those practices across teams building similar you will champion automation-first DevSecOps-oriented quality practices to build the documentation and process infrastructure that allows developers to focus on writing great product code not wrestling with regulatory paperwork. This role does not manage people it leads through technical credibility persuasion and partnership.
What you will do as aSoftware Quality Assurance Engineer:
Embed with engineering teams to understand existing documentation practices and automation tools for software design V&V activities and change control then produce standardized templates work instructions and SOPs that can be applied consistently across teams with similar cloud-native product lines.
Serve as the primary author and owner of software lifecycle documentation artifacts including Software Development Plans (SDPs) Software Requirements Specifications (SRS) Software Design Documents (SDD) Verification & Validation Plans and Reports and Software Risk Management Files
Drive document change control processes from initiation through approval coordinating review cycles to keep releases on schedule.
Establish and maintain traceability matrices linking software requirements design elements risk controls test cases and defects ensuring end-to-end objective evidence is audit-ready at any point in the release cycle.
Own the documentation project plan for each software release tracking open documentation tasks review cycles and approval gates as a parallel workstream to the engineering release schedule.
Facilitate documentation readiness reviews prior to design freeze test execution and regulatory submission milestones. Communicate readiness status to engineering leads; escalate blockers early and drive resolution.
To succeed as a Software Quality Assurance Engineer you will need the followingexperience and skills:
Bachelors degree in Computer Science Software Engineering or a closely related technical discipline required.
Advanced degree or professional certifications (ASQ CSQE ISTQB RAC) a plus but not required in lieu of demonstrated experience).
58 years of combined experience in software quality engineering software development or a closely adjacent technical role with at least 2 years in an FDA-regulated environment (medical devices digital health or pharmaceutical software).
Hands-on software development background you must be able to read and reason about Go Java or Python code Infrastructure-as-Code (Terraform Ansible) and automated test code (Playwright pytest) without requiring a developer to walk you through it.
Demonstrated experience producing IEC 62304-compliant documentation for Class B or Class C software
Practical knowledge of ISO 14971 risk management methodology as applied to medical device software; experience authoring or materially contributing to FMEAs and software hazard analyses.
Working knowledge of FDA cybersecurity expectations for medical devices including familiarity with NIST frameworks and the ability to assess cloud-hosted systems against those standards.
Familiarity with cloud-native architectures (microservice and event-driven architectures at scale networking IAM) sufficient to understand system design documents and workflows.
Direct experience writing automated tests in Python or Go or using Playwright for UI/E2E test automation
The ideal candidate:
You default to automation and repeatability over manual processes and you can articulate why that matters for regulatory defensibility not just engineering velocity.
You are a skilled communicator who can translate between regulatory language and engineering language equally comfortable in a design review with a Go developer and a regulatory affairs meeting.
You take documentation quality as seriously as software quality: clarity precision version control and traceability are not overhead to you they are the work.
You are comfortable working independently across multiple teams managing your own priorities and driving cross-functional coordination without formal authority.
About DEKA:
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.
Required Experience:
Manager
DEKA Research & Development is looking for a technically deep process-driven Software Quality Assurance Engineer to join our cloud engineering team. This is an individual contributor role with outsized organizational impact: you will work alongside cloud-native engineering teams ...
DEKA Research & Development is looking for a technically deep process-driven Software Quality Assurance Engineer to join our cloud engineering team. This is an individual contributor role with outsized organizational impact: you will work alongside cloud-native engineering teams to learn how they work codify documentation best practices and scale those practices across teams building similar you will champion automation-first DevSecOps-oriented quality practices to build the documentation and process infrastructure that allows developers to focus on writing great product code not wrestling with regulatory paperwork. This role does not manage people it leads through technical credibility persuasion and partnership.
What you will do as aSoftware Quality Assurance Engineer:
Embed with engineering teams to understand existing documentation practices and automation tools for software design V&V activities and change control then produce standardized templates work instructions and SOPs that can be applied consistently across teams with similar cloud-native product lines.
Serve as the primary author and owner of software lifecycle documentation artifacts including Software Development Plans (SDPs) Software Requirements Specifications (SRS) Software Design Documents (SDD) Verification & Validation Plans and Reports and Software Risk Management Files
Drive document change control processes from initiation through approval coordinating review cycles to keep releases on schedule.
Establish and maintain traceability matrices linking software requirements design elements risk controls test cases and defects ensuring end-to-end objective evidence is audit-ready at any point in the release cycle.
Own the documentation project plan for each software release tracking open documentation tasks review cycles and approval gates as a parallel workstream to the engineering release schedule.
Facilitate documentation readiness reviews prior to design freeze test execution and regulatory submission milestones. Communicate readiness status to engineering leads; escalate blockers early and drive resolution.
To succeed as a Software Quality Assurance Engineer you will need the followingexperience and skills:
Bachelors degree in Computer Science Software Engineering or a closely related technical discipline required.
Advanced degree or professional certifications (ASQ CSQE ISTQB RAC) a plus but not required in lieu of demonstrated experience).
58 years of combined experience in software quality engineering software development or a closely adjacent technical role with at least 2 years in an FDA-regulated environment (medical devices digital health or pharmaceutical software).
Hands-on software development background you must be able to read and reason about Go Java or Python code Infrastructure-as-Code (Terraform Ansible) and automated test code (Playwright pytest) without requiring a developer to walk you through it.
Demonstrated experience producing IEC 62304-compliant documentation for Class B or Class C software
Practical knowledge of ISO 14971 risk management methodology as applied to medical device software; experience authoring or materially contributing to FMEAs and software hazard analyses.
Working knowledge of FDA cybersecurity expectations for medical devices including familiarity with NIST frameworks and the ability to assess cloud-hosted systems against those standards.
Familiarity with cloud-native architectures (microservice and event-driven architectures at scale networking IAM) sufficient to understand system design documents and workflows.
Direct experience writing automated tests in Python or Go or using Playwright for UI/E2E test automation
The ideal candidate:
You default to automation and repeatability over manual processes and you can articulate why that matters for regulatory defensibility not just engineering velocity.
You are a skilled communicator who can translate between regulatory language and engineering language equally comfortable in a design review with a Go developer and a regulatory affairs meeting.
You take documentation quality as seriously as software quality: clarity precision version control and traceability are not overhead to you they are the work.
You are comfortable working independently across multiple teams managing your own priorities and driving cross-functional coordination without formal authority.
About DEKA:
One hour from the beach Boston and the mountains the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research & Development where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKAs brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering design and manufacturing. Here at DEKA some of the most innovative and life-changing products of our time are created and new ideas are always welcome and explored.
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it
... View more
Job Location:
Monthly Salary:
Posted on:
Vacancies:
