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Who We Are
Cerebra Medical Ltd. is a fast-growing start-up, located in Winnipeg, MB. We are a digital health-tech company focused on improving lives by changing the way the world looks at sleep. The future of the sleep lab is in the home, where a patient’s sleep really occurs. We have realized this vision through our approved medical devices and patented Odds Ratio Product, unique assets that set us apart from competitors. Coupled with an R&D team comprised of world-class sleep experts, our approach is revolutionizing the assessment and management of sleep and sleep disorders, and we’ve only just begun.
At Cerebra Medical, we are big promoters of Agile and CI/CD. We strive to instill this in each of our projects. Our team is small and nimble. We are passionate about software quality, security, and the end-user experience. Our tech stack employs the latest technologies from top (Android applications) to bottom (proprietary IoT devices), with a mature analytics suite in between to provide our clients with the latest insights in sleep science at scale. Whatever your tech passion, you can find it here. Our product roadmap is driven by our customers and the cutting-edge research being done by our dedicated team of sleep scientists.
The Role
The Software Business Analyst is responsible for performing detailed requirements analysis, documenting requirements and processes, and becoming a subject matter expert on our products. The Business Analyst will be required to work across multiple stakeholder groups to ensure user needs are met. Central to the job is working closely with Product Management to translate end user and stakeholder requirements into detailed requirements for the Development team. The use of tools such as Jira will be a routine task. The job includes maintaining compliance with medical device software standards including IEC 60601 and 62304. The Software Business Analyst will apply creative customer-focused solutions necessary to support the safety and effectiveness of our product while delivering a superior experience for our end-use customers.
Responsibilities
Working with Product Management, ensures that needs of stakeholders are analyzed and clearly specified.
Collaborates with Product Management, the Project Manager, and stakeholders to define and document project scope and vision.
Assuming the role of Product Owner, ensures that our feature backlog stays groomed and current, and verifies requirements for completeness, consistency, comprehensibility, feasibility, and conformity to standards.
Translates conceptual customer requirements into functional requirements / technical specifications in a clear manner that is comprehensible to developers/project team.
Supports the Development team with preparation of documents in compliance with company SOP’s, ISO 13485, IEC 62304, IED 60601, FDA, Health Canada and any other relevant regulatory standard or policy.
Creates process models, specifications, diagrams, and charts to provide direction to developers and/or the project team.
Develops and conducts peer reviews to ensure that requirements are correctly interpreted.
Drives triage of issues identified during verification & validation as well as those escalated from technical support.
Actively participates in product verification and validation to ensure features / functions have been enabled and optimized.
Owns, coordinates and contributes to updating medical device design history files.
Develops in-depth technical understanding of the product software and hardware.
Skills and Experience
What you’ll need to succeed
Bachelor’s degree.
2+ years business analyst experience in a fast paced, multi-project environment.
Knowledge of multiple SDLC methodologies, standards, procedures and organization that contribute to the development and deployment of technology solutions.
Able to exercise independent judgment and act upon it.
Excellent analytical and creative problem-solving skills.
Excellent listening, interpersonal, written, and oral communication skills.
Logical and efficient, with keen attention to detail.
Highly self-motivated and self-directed.
Ability to effectively prioritize and execute tasks while under pressure.
Strong customer service orientation.
Experience working in a team-oriented, collaborative environment.
What we would love to see
Familiar with Agile/Scrum development methodologies.
Software-as-a-medical-device experience.
Proficient knowledge of medical device QMS and Design Control requirements, including ISO 13485 and 21 CFR part 820.
Understanding of standards related to medical device development, including IEC 62304, IEC 60601, IEC 62366 and ISO 14971.
Benefits
At Cerebra, we offer a contemporary, fast paced, growth-oriented work environment that affords equal opportunities and embraces diversity. We provide enriching and satisfying careers for our employees, work hard, and have fun in the process. A competitive compensation package, inclusive of insurance benefits will be offered to the successful candidate.
Cerebra Medical Ltd. is a wholly owned subsidiary of Cerebra Health Inc. For more information on Cerebra Health, visit: www.cerebra.health.
We thank all applicants for their interest, however, only those under consideration will be contacted for an interview.