Embedded Software Architect

This is a fully remote position, open to applicants in Romania.

📋 Description

• Oversee the design and execution of automated testing frameworks for innovative medical devices.

• Provide strategic direction for the verification and validation of embedded systems and cloud-connected solutions.

• Contribute to product concepts and strategies for design-for-test during the early stages of development.

• Conduct feasibility studies for new testing technologies and their integration into workflows.

• Lead and coordinate verification and validation activities for medical device software.

• Manage test planning, execution, defect tracking, tool validation, documentation, and audit preparedness.

• Drive the automation strategy, selection of tools, and design of modular test frameworks.

• Develop and sustain test suites across software, GUI, and hardware layers.

• Ensure quality throughout the software development lifecycle and testing lifecycle via test planning and traceability.

• Mentor teams in automation, coding best practices, and compliance with regulatory standards.

• Establish standards for code reviews, version control, and reusable testing assets.

• Facilitate workshops and promote continuous learning initiatives.

• Align testing efforts with project objectives and timelines through collaboration with stakeholders and management.

• Collaborate with external partners and oversee vendor contributions.

• Spearhead continuous improvement initiatives utilizing Agile practices, metrics, and contemporary tools.

• Assess emerging technologies such as AI/ML for testing embedded devices and cloud platforms.

• Plan and organize complex project assignments and milestones.

• Research, develop, design, and evaluate engineering materials, components, assemblies, processes, and equipment.

• Develop concepts from initial design stages through to market launch.

• Direct support personnel and coordinate project activities effectively.

• Write and submit patents and technical articles for journals.

• Maintain comprehensive documentation for research and development efforts.

• Interface with senior management on critical matters.

• Provide technical leadership, mentoring, training, and guidance to team members.

• Independently exercise judgment and select appropriate methods to guide projects to successful completion.

⛳️ Requirements

• Bachelor's degree in Software Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related field.

• Over 9 years of experience in architecting, designing, developing, debugging, reviewing, and testing embedded software.

• A minimum of 2 years of experience in leading teams of embedded engineers.

• At least 6 years of experience in medical device engineering, verification and validation, or related domains.

• A minimum of 5 years leading test automation projects for regulated medical devices.

• Extensive knowledge in a specific technological area.

• Thorough understanding of business unit functions and interdependencies across groups.

• Acknowledged as an expert within the work group and across various functions.

• Experience in a quality system environment and adherence to governmental regulations.

• Capability to tackle complex issues requiring a detailed assessment of numerous factors.

• Broad understanding of technical alternatives and their potential business implications.

• Associate Certified Coach (ACC) ICF certification.

• Master's degree in a relevant engineering field or equivalent (preferred).

• Experience with FDA Class II/III regulations (highly desirable).

🏝️ Benefits

• Equal opportunity employer.

• Reasonable accommodation for qualified individuals with disabilities.