About this Role:As a Senior Systems Engineer II -
Platform Services 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
Location:Remote - US
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range$138,000.00 - $180,000.00
