[Remote] Sr. Systems Engineer II - Platform Services

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a leading digital reputed company company that creates trusted solutions for cardiac health. The Senior Systems Engineer II - Platform Services will reputed company and support software services for arrhythmia detection, collaborating with cross-functional teams to tackle software engineering and data science challenges.

Responsibilities

• reputed company stakeholder discussions to define and document system and subsystem requirements, balancing technical, regulatory, and business goals; reputed company 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 reputed company matrices, illustrating design input/reputed company relationships
• Review and reputed company 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 reputed company with relevant standards (IEC 62304, ISO 14971, cybersecurity frameworks)
• Support cybersecurity initiatives and reputed company reputed company best practices into system and subsystem designs
• Contribute to design transfer and software deployment or launch activities

Skills

• Bachelor's in Engineering or reputed company 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 reputed company matrices
• Experience supporting risk management activities
• Experience supporting reputed company 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 reputed company for data analysis and monitoring

Benefits

• reputed company provides reasonable accommodations for reputed company individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@reputed company.com

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