Senior Systems Engineer II – ECG Monitoring Applications

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

📋 Description

• Facilitate discussions with stakeholders to establish and document requirements for systems and subsystems.

• Keep comprehensive documentation and models of system architecture (e.g., SysML).

• Assist in the post-market evaluation of algorithm performance, including scripting in Python.

• Participate in risk management processes and investigations related to field complaints.

• Oversee the management of end-to-end product trace matrices that demonstrate the relationships between design inputs and outputs.

• Assess and provide technical feedback on design deliverables such as software specifications, design documents, test plans, and reports.

• Work collaboratively with cross-functional teams to create workflows and ensure effective system integration.

• Perform compliance gap assessments, aid in regulatory submissions, and keep abreast of relevant standards.

• Support cybersecurity efforts and incorporate security best practices into system and subsystem designs.

• Assist in design transfer and activities related to software deployment or product launch.

⛳️ Requirements

• Bachelor’s degree in Engineering or a related discipline.

• A total of over 8 years of experience in systems engineering (with a Bachelor's degree).

• Minimum of 2 years of experience in the development of software-based medical devices (SaMD/SiMD).

• Basic understanding of statistics, including the calculation of algorithm performance metrics (e.g., sensitivity, specificity).

• Proficiency in software development using one or more of the following: Python (or an equivalent scripting language), Java, C#, or C/C++.

• Experience in developing technical product/software requirements, system architecture, and trace matrices.

• Background in supporting risk management activities.

🏝️ Benefits

• Health insurance

• 401(k)

• Paid time off

• Professional development

• Remote work options