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 systemlevel requirements.
Develop requirements trace matrices and verification trace matrices.
MustHaves:
5 years of experience in software requirements engineering for mobile and/or wearable applications.
Strong understanding of mobile and wearable application architecture including platformspecific considerations (iOS Android Wear OS).
Proven ability to write clear concise and testable endtoend software requirements.
Experience with requirements management tools (e.g. Jama Connect).
Excellent communication interpersonal and collaboration skills.
Responsibilities:
Elicit analyze document and manage endtoend software requirements for Clients 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 V&V and other relevant documentation.
Collaborate with crossfunctional 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 uptodate on industry best practices for mobile and wearable application development.
Required Skills (top 3 nonnegotiables):
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 platformspecific 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.