Embedded Software Architect

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.

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. 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.

·         As a team lead, lead & 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).

·         Planning/Organization-Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones. Establishes priorities of individual or project assignments.

·         Influence/Leadership-Understands business environment and relates extensive knowledge of internal and external technological activities to trends.

·         Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.

·         Conducts feasibility studies to verify capability and functionality.

·         Develops new concepts from initial design to market release.

·         Directs support personnel and coordinates project activities.

·         Write and submit intellectual property (patents).

·         Maintains detailed documentation throughout all phases of research and development.

·         Investigates and evaluates existing technologies.

·         Reviews or coordinates vendor activities to support development.

·         Write and submit professional articles for technical journals.

·         Influence/Leadership-Understands business environment and relates extensive knowledge of internal and external technological activities to trends.

·         Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.

·         Participates in the development of other technical contributors by facilitating training and providing feedback and guidance.

·         May lead a project team.

·         Provides technical leadership to business units. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees.

·         Exercises judgment independently.

·         Decision Making/Impact-Selects methods and techniques to lead a project to completion. Erroneous decisions or recommendations would typically result in failure to achieve major organizational objectives.

 

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

Bachelor of Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent

PREFERRED QUALIFICATIONS:

Master’s degree of Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering or equivalent

9+ years of experience in architecting, designing, developing, debugging, reviewing and testing embedded software and at least 2 years leading teams of embedded engineers in that minimum 6+ years- of experience in medical device engineering, verification & validation, or related fields, minimum 5+ years - leading test automation efforts for regulated medical devices (FDA Class II/III experience highly desirable).

Technical/Business Knowledge (Job Skills)-Comprehensive knowledge of a particular technological field.

Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.

Is recognized as an expert in work group and across functions.

Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Cognitive Skills-Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.

Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Has broad knowledge of various technical alternatives and their potential impact on the business.

Associate Certified Coach (ACC) ICF certification

COMPETENCIES:

Drives for Results: Acts ethically and takes accountability   for achieving outcomes.

Fosters Collaboration: Comfortable with ambiguity. Implements change when needed.

Focuses on Customers: Promptly and effectively handles issues and problems.

 

 

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.