Sr. Systems Engineer II - ECG Monitoring Applications

About this Role:

As a Senior Systems Engineer II - ECG Monitoring Applications in the Research & Systems Engineering team, you will be instrumental in developing and supporting software services enabling during-wear arrhythmia detection and reporting. By collaborating with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies, Product/UX, Product Security, and Clinical, you will tackle a wide range of software engineering and data science challenges to address unmet clinical needs. This role gives you the chance to work alongside a skilled team, gain an in-depth understanding of our integrated systems, and contribute to the successful completion of software projects throughout their development cycle.

Key Responsibilities:

• Lead stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals; perform trade-off analyses and present recommendations to leadership for alignment.

• Maintain detailed system architecture documentation and models (e.g., SysML), ensuring accurate system representation.

• Support post-market monitoring of algorithm performance, including scripting (Python), and contribute to risk management and field complaint investigations.

• Manage end-to-end product trace matrices, illustrating design input/output relationships

• Review and provide technical input to design deliverables like software specifications, design documents, test plans, and reports.

• Collaborate with cross-functional teams to establish workflows and ensure seamless system integration.

• Conduct compliance gap assessments, assist with regulatory submissions, and stay current with relevant standards (IEC 62304, ISO 14971, cybersecurity frameworks).

• Support cybersecurity initiatives and integrate security best practices into system and subsystem designs.

• Contribute to design transfer and software deployment or launch activities.

About You:

You...

• Are quality-minded with the ability to dive into technical details while still having the big picture in mind

• Enjoy investigative and troubleshooting processes using your excellent analytical and problem-solving skills

• Are self-motivated and demonstrate initiative in helping others

• Have effective presentation and interpersonal skills

Required Qualifications:

• Bachelor's in Engineering or related field;

• Combined 8+ years of systems engineering experience (with a Bachelors), with at least 2 years of experience working on developing software-based medical devices (SaMD/SiMD). Note: Candidates with a Master's or PhD may qualify with fewer years of relevant experience.

• Understanding the basics of statistics - including calculation of algorithm performance metrics (e.g., sensitivity, specificity).

• Experience with software development using one or more of Python (or equivalent scripting language), Java, C#, or C/C++.

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

• Experience supporting risk management activities.

Preferred Qualifications:

• Experience supporting projects employing Scrum and Agile methodologies

• Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1)

• Proficiency in the use of requirements management tools, such as Jama, Polarion, or DOORs

• Knowledge of INCOSE/EARS best practices and guidelines; ASEP/CSEP certification considered advantageous

• Knowledge of SysML, UML, or broadly, Model-Based Systems Engineering (MBSE)

• Experience using Splunk for data analysis and monitoring