Sr. Systems Engineer II - ECG Monitoring Applications

About this Role:

As a Senior Systems EngineerII - ECG Monitoring Applicationsin the Research & Systems Engineering team, you will be instrumental in developing and supportingsoftware services enablingduring-weararrhythmia detectionand reporting.By collaborating with specialists in Data Science/Machine Learning, Software Engineering, Mobile Technologies,Product/UX,Product Security,and Clinical,youwill tackle a wide range of software engineering and data science challenges toaddress unmetclinical 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.

KeyResponsibilities:

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

• Maintain detailed system architecture documentation and models (e.g.,SysML), ensuringaccuratesystem 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 likesoftware specifications, design documents, test plans, and reports.

• Collaborate with cross-functionalteams 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…

• Arequality-minded withtheability todive into technical detailswhilestillhaving the big picture in mind

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

• Areself-motivated and demonstrate initiative in helping others

• Have effective presentation and interpersonal skills

RequiredQualifications:

• Bachelor’s inEngineeringor relatedfield;

• Combined8+yearsofsystems engineering experience(with a Bachelors),withat least 2 years ofexperienceworking on developingsoftware-based medical devices (SaMD/SiMD).Note: Candidates with aMaster’sor PhD may qualify with fewer years of relevant experience.

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

• Experiencewith software development usingone or more ofPython (or equivalent scripting language), Java, C#,orC/C++.

• Experience developing technical product/software requirements, systemarchitectureand trace matrices.

• Experiencesupportingrisk managementactivities.

PreferredQualifications:

• Experiencesupportingprojects employing Scrum and Agile methodologies

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

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

• Knowledge of INCOSE/EARSbest practices and guidelines; ASEP/CSEP certificationconsideredadvantageous

• Knowledge ofSysML, UML,orbroadly,Model-Based Systems Engineering (MBSE)

• ExperienceusingSplunk for data analysis and monitoring