Systems Engineer

We are seeking an experienced Software Systems Engineer to serve as both an individual contributor and team lead within a fast-paced medical device environment. This role will support the Heart Failure (HF) business unit and focus on end-to-end systems engineering activities, from requirements development through design validation and documentation., * Lead and execute requirements elicitation, decomposition, and traceability

• Develop and maintain:

• dFMEAs
• SysML models and software/system architecture
• Development plans and trade-off studies
• Traceability matrices

• Lead technical software design reviews for key deliverables
• Author and maintain high-quality internal design documentation for engineering and cross-functional teams
• Validate design patterns and continuously improve engineering processes and documentation
• Coordinate implementation activities, including:

• Project and task execution
• Device documentation
• Cross-training of team members

• Stay current with emerging software and infrastructure technologies and provide recommendations

• 5+ years of systems engineering experience
• Proven experience as a Software Systems Engineer in a medical device company
• Strong background in software requirements development
• Experience working within an Agile development lifecycle
• Experience with requirements management tools
• Knowledge of regulatory standards:

• FDA 21 CFR Part 820
• EU MDR, * Bachelor's degree required, * Strong verbal and written communication skills across all organizational levels

• Ability to work:

• Independently and as a team lead
• In geographically distributed teams

• Proven ability to multitask, prioritize, and meet deadlines
• Strong collaboration and problem-solving skills
• Reliable attendance and accountability