Job Summary:
The Software Requirements Engineer is a key member of the software product team, responsible for gathering, analyzing, and documenting software requirements from stakeholders and ensuring they are accurately implemented in our medical device software products. This role involves close collaboration with both technical and business product teammates to ensure that software solutions meet customer needs and are delivered to the highest quality standards.
Key Responsibilities:
• Collaborate with product team members and stakeholders to gather and document detailed software requirements and ensure a clear understanding of their needs
• Analyze product requirements and software architecture to create clear and succinct software requirements
• Determine the appropriate solution based on stakeholder need, quality, and feature prioritization.
• Comprehend and communicate complex solutions provided by multiple engineering domains
• Serve as liaison between product owners and the software development team to ensure requirements are accurately implemented
• Participate in the development of epics, user stories, use cases and scenarios to support design and development
• Lead and organize meetings as appropriate and communicate status of work activities to leaders, product teammates, and stakeholders
• Conduct requirements design review meetings and participate in software design discussions
• Assist in managing changes to requirements through effective change control processes and tools
• Assist in the validation and verification of software functionality against requirements
• Support the development of test plans and test cases to ensure requirements are understood and met
Qualifications:
• Bachelor’s degree in Biomedical Engineering, Software Engineering, or related field
• minimum 3+ years experience in software requirements analysis or systems engineering role
• Experience with medical device software
• Strong understanding of software development methodologies (e.g. Agile, Waterfall)
• Collaborative and problem-solving mindset
• Self-driven, accountable teammate
• Excellent communication and interpersonal skills, with the ability to interact effectively with both technical and non-technical stakeholders
Preferred Qualifications:
• Experience with requirements management tools (e.g. Azure, Jira, IBM Doors Next Generation, Windchill)
• Experience with risk management
• Knowledge of basic networking and cybersecurity needs
• Knowledge of modeling techniques (e.g., UML, BPMN)
• Knowledge of IEC 62304 and IEC 60601
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Additional Information
Envision, LLC is proud to be an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
