Role Overview
Abbott Rapid Molecular Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support point of care diagnostic testing that provides important information for treatment and management of diseases and other conditions.
This role is responsible for leading the design and implementation of automated testing frameworks for novel medical devices, with a focus on verification and validation (V&V) of embedded systems and cloud-connected solutions. The Embedded Software Architect provides strategic guidance to ensure regulatory compliance and testing efficiency, collaborates with offshore cross-functional teams to support the delivery of safe, high-quality products, and contributes to early concept development and feasibility assessments to embed testability and quality from the outset.
Responsibilities
- Contribute to product concepts and design-for-test strategy in early development.
- Lead feasibility studies for new test technologies and integration into workflows.
- Lead and coordinate the verification and validation (V&V) activities for medical device software, ensuring compliance with regulatory standards (e.g., FDA, ISO 13485, IEC 62304).
- Oversee test planning, execution, and defect management, while mentoring team members, collaborating cross-functionally, and driving continuous improvement in test processes and quality assurance.
- Drive automation strategy, tool selection, and modular test framework design.
- Develop and maintain test suites across software, GUI, and hardware layers.
- Ensure quality across SDLC/STLC phases through robust test planning and traceability.
- Oversee tool validation, documentation, and audit readiness.
- Mentor teams in automation, coding practices, and regulatory standards.
- Define standards for code reviews, version control, and reusable test assets.
- Facilitate workshops and drive continuous learning initiatives.
- Interface with stakeholders and management to align testing with project goals and timelines.
- Collaborate with external partners and manage vendor contributions.
- Lead continuous improvement of test processes via Agile, metrics, and modern tools.
- Evaluate emerging technologies (e.g., AI/ML in testing embedded devices or cloud platforms).
- Plan and organize project assignments of substantial variety and complexity.
- Research, develop, design, and evaluate mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
- Develop new concepts from initial design to market release.
- Write and submit intellectual property (patents) and professional articles for technical journals.
- Interface with senior management on significant matters.
The company provides opportunities for professional growth through mentoring, leadership of project teams, and involvement in the development of other technical contributors by facilitating training. The role involves working in a high-impact environment where the individual acts as a technical leader across business units.
Education
- Bachelor of Science in Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent.
Preferred Qualifications
- Master’s degree of Science in Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent.
- 9+ years of experience in architecting, designing, developing, debugging, reviewing and testing embedded software.
- At least 2 years leading teams of embedded engineers.
- 6+ years of experience in medical device engineering, verification & validation, or related fields.
- 5+ years leading test automation efforts for regulated medical devices (FDA Class II/III experience highly desirable).
- Comprehensive knowledge of a particular technological field and business unit functions.
- Associate Certified Coach (ACC) ICF certification.
Competencies
- Drives for Results: Acts ethically and takes accountability for achieving outcomes.
- Fosters Collaboration: Comfortable with ambiguity and implements change when needed.
- Focuses on Customers: Promptly and effectively handles issues and problems.
