DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
Meghna at 224 369 4230
Infant at 224 507 1261
Title: Systems Engineer (EU MDR)- Remote
Location: Remote
Duration: 12 Months
Job Description :
Knowledge of EU MDR submissions and regulations
5 years of experience in requirements engineering with excellent understanding of INCOSE requirements engineering best practices and EARS requirements writing guidance
Trace requirements (hardware, software, and systems) to parent subsystems and system-level requirements.
Develop requirements trace matrices and verification trace matrices.
Must-Haves:
5 years of experience in software requirements engineering for mobile and/or wearable applications.
Strong understanding of mobile and wearable application architecture, including platform-specific considerations (iOS, Android, Wear OS).
Proven ability to write clear, concise, and testable end-to-end software requirements.
Experience with requirements management tools (e.g., Jama Connect).
Excellent communication, interpersonal, and collaboration skills.
Responsibilities:
Elicit, analyze, document, and manage end-to-end software requirements for Client's CGM mobile and wearable applications.
Apply INCOSE guidelines to write clear, concise, complete, and testable product requirements.
Develop and maintain software requirements specifications, use cases, user stories with POs, test cases with VandV and other relevant documentation.
Collaborate with cross-functional teams (e.g., SDK, Data Cloud Platform, Mobile App, Wearable App) to allocate requirements and ensure seamless integration.
Define and document interfaces between mobile/wearable applications and other system components (e.g., CGM device, cloud platform).
Create and maintain traceability between product requirements, interface specifications, design documents, and test cases.
Participate in design reviews, code reviews, and testing activities to ensure requirements are met.
Stay up-to-date on industry best practices for mobile and wearable application development.
Required Skills (top 3 non-negotiables):
Ex: Agile Experience 2 Years minimum
1. Extensive experience in software requirements engineering for mobile/wearable applications.
2. Strong understanding of mobile and wearable application architecture.
3. Proven ability to write clear, concise, and testable requirements according to INCOSE guidelines.
Preferred Skills (nice to have):
Ex: Case Management Experience 3 years
1. Experience with medical device software development.
2. Familiarity with CGM technology.
3. Experience with Agile development methodologies.
Education Requirements: Minimum Bachelors experience, MS preferred.
Required Testing:
Specific technical assessments (coding challenges, requirements writing exercises).
Personality assessments to evaluate cultural fit.
Software Skills Required:
Understand Product development lifecycle; Agile; SDLC ISO 62304
Proficiency in at least one mobile development platform (iOS/Swift, Android/Kotlin).
Experience with relevant IDEs (Xcode, Android Studio).
Familiarity with version control systems (Git).
Knowledge of software testing methodologies.
Experience with requirements management tools (e.g., Jama, Jira).
Understanding of mobile/wearable application design patterns (MVC, MVVM).
Experience with communication protocols (e.g., Bluetooth, RESTful APIs).
Required Certifications:
Relevant platform-specific certifications (e.g., Android Certified Application Developer).
Agile certifications (e.g., Certified Scrum Master).
INCOSE certifications (ASEP, CSEP) are a plus if related to requirements engineering, but not essential for this level.
About us:
DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.