Summary
GlobalLogic is a digital engineering partner that develops digital products, platforms, and services for global companies. The Product Owner will manage the Android application backlog for Pod OTA and Pod Communication features in safety-critical, regulated diabetes-care software, coordinating with engineering, QA, regulatory, and hardware/firmware teams. The role also involves defining user stories and acceptance criteria, supporting release planning, and ensuring medical device compliance documentation.
Responsibilities
- Backlog Ownership: Own and manage the product backlog for the Android application, specifically for Pod OTA and related Pod Communication features
- User Stories & Acceptance Criteria: Write clear, detailed user stories and acceptance criteria to ensure engineering teams understand what to build and how to test it
- Cross-Functional Collaboration: Partner closely across teams, including Engineering, QA, Regulatory, and Hardware/Firmware groups
- Release Planning: Actively assist with and support release planning efforts
- Medical Device Compliance: Ensure all changes and modifications are thoroughly documented to meet medical device compliance standards, including design documentation and risk assessments
- QA & Test Case Definition: Assist QA in defining test cases for real-world scenarios in connection with Acceptance Criteria and Software Requirement Specifications (SRSs)
Skills
- Bachelor's degree + 3 or more years of relevant experience (or 8+ years of experience without a degree)
- Experience in Medical Device development or highly regulated products
- Agile/SAFe methodologies in a Product Owner role
- Knowledge of embedded software, firmware, and hardware development
- Demonstrated experience working as a Product Owner within the MedTech / Medical Device industry
- Hands-on experience with regulated software delivery, including documenting changes for medical device compliance (design docs, risk assessments, and SRSs)
- Experience in Android mobile application development and device connectivity, specifically related to Pod OTA and Pod Communication features
- Strong communication skills across technical and non-technical audiences
- Experience with diabetes technology products
- Mobile Application or Cloud development background
- Proactive stakeholder communication
- Understanding of medical device regulations and standards (e.g. ISO 13485, IEC 62304, ISO 14971, EU MDR)
- Experience in FDA Pre-Submissions, FDA clearance, PCCP Framework Knowledge
- Familiarity with UI/UX principles and experience collaborating with UX/UI design teams
- Detail-oriented with strong written and verbal skills
Qualifications
Must Haves
- Bachelor's degree + 3 or more years of relevant experience (or 8+ years of experience without a degree)
- Experience in Medical Device development or highly regulated products
- Agile/SAFe methodologies in a Product Owner role
- Knowledge of embedded software, firmware, and hardware development
- Demonstrated experience working as a Product Owner within the MedTech / Medical Device industry
- Hands-on experience with regulated software delivery, including documenting changes for medical device compliance (design docs, risk assessments, and SRSs)
- Experience in Android mobile application development and device connectivity, specifically related to Pod OTA and Pod Communication features
- Strong communication skills across technical and non-technical audiences
Nice to Haves
- Experience with diabetes technology products
- Mobile Application or Cloud development background
- Proactive stakeholder communication
- Understanding of medical device regulations and standards (e.g. ISO 13485, IEC 62304, ISO 14971, EU MDR)
- Experience in FDA Pre-Submissions, FDA clearance, PCCP Framework Knowledge
- Familiarity with UI/UX principles and experience collaborating with UX/UI design teams
- Detail-oriented with strong written and verbal skills
Benefits
- Exciting projects using the latest technologies and opportunities to work on market-defining products
- Collaborative environment with a diverse team of highly talented people in an open, laidback environment
- Opportunities to work abroad in one of GlobalLogic’s global centers or client facilities
- Flexible work schedules and opportunities to work from home
- Continuing education classes and professional certification and training in technical, soft skills, language, and communication skills
- Additional learning opportunities through international knowledge exchanges
- Health and life insurance
- Short-term and long-term disability insurance
- Matched contribution 401K plan
- Flexible spending accounts
- PTO and holidays