Job Summary:
We are seeking a highly motivated and skilled Software Requirements Engineer to join our team as a key member of the software product team, responsible for obtaining, 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. The ideal candidate has a strong background in medical devices with a proven track record of collaborating with cross-functional teams to drive towards customer outcomes.
Key Responsibilities:
• Collaborate effectively with product team members and functional stakeholders to gather and document detailed software requirements, ensuring a comprehensive understanding of their needs.
• Identify and determine the most appropriate solutions based on stakeholder requirements, quality standards, and drive feature prioritization.
• Facilitate and drive conversations to help stakeholders come to a consensus on requirements, ensuring alignment and clarity.
Requirements Gathering:
• Collaborate closely with clinical, regulatory, service, and software teams to gather software product requirements creating clear and succinct design inputs.
• Identify and determine the most appropriate solutions based on customer needs, quality standards, and feature prioritization.
• Understand and communicate complex solutions provided by multiple engineering domains.
• Act as a liaison between product owners and the software development team to ensure accurate implementation of requirements.
• Engage actively in the development of epics, user stories, use cases, and scenarios to support design and development.
• Lead and organize meetings as needed and communicate the 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.
Verification and Validation:
• Assist in testing when necessary to support the testing process.
• Ensure that the requirements written can be translated into test cases, maintaining high standards of accuracy and reliability.
Qualifications:
• Bachelor’s degree in Biomedical Engineering, Software Engineering, or related field
• Master’s degree or minimum 4+ years’ experience in software requirements analysis, business analyst or systems engineering role
• 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
• Prior experience with medical devices
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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