Infostretch is a pure-play digital engineering services firm focused on helping companies accelerate their digital initiatives from strategy and planning through execution. We leverage deep technical expertise, Agile methodologies and data-driven intelligence to modernize systems of engagement and simplify human/tech interaction. We deliver custom solutions that meet customers’ technology needs wherever they are in their digital lifecycle. Backed by Goldman Sachs and Everstone Capital, Infostretch works with both large enterprises and emerging innovators -- putting digital to work to enable new products and business models, engage with customers in new ways, and create sustainable competitive differentiation.
The Software Architect position will be working with the product and software engineering team to ensure different customer solutions are designed, architected, documented, and implemented according to medical device design and development requirements from regulatory bodies.
We are looking for someone who thrives in a start-up environment and demonstrates:
- Intensely collaborative
- Passionately focused on the customer
- Detail oriented
- Disciplined executor of responsibilities
- Tenacious commitment to continuous improvement
- Relentless drive to win
- Intense curiosity on technology
- Flexibility and willingness to learn Here is a glimpse of what you’ll do
- Lead design, architecture, and development of software-based medical devices.
Activities will encompass all facets and phases of software design and development, test, and life cycle management, meeting all regulatory, quality, data privacy, and cybersecurity standards to realize complex, high-performing, and reliable software solutions.
- Knowledge of cloud architecture, data management. Mobile application development will be plus.
- Collaborate with the systems engineering and product teams to understand and define customer products use cases and convert these use cases into software requirements and architecture and design implementations.
- Own and lead the software engineering team throughout the software development life cycle, including sub-system architecture and design specifications, code review, unit and integration testing, software FMEA, performance analysis, reliability analysis, and root cause analysis.
- Ensure traceability of software requirements into software architecture and design specifications all the way down to base software units.
- Provide support for accurate and complete software verification and validation at the system and unit levels
- 7+ years of hands-on software development experience
- 7+ years of experience in software medical device development
- 7+ years of experience in multiple IT disciplines gained in the pharmaceutical/healthcare/life science industry and/or for a top software consultancy firm
- Demonstrated applied expertise in writing architecture and design specifications for Class 2 and/or Class 3 software-based medical device software with compliance to IEC 62304 - good to have
- Experience in working in an environment following Agile methodology
- Demonstrated applied expertise with Software FMEA process
- Familiarity with SaMD development – good to have
- Experience leading nearshore and/or offshore development partners
- Familiarity with health and data privacy regulations
- Provide coaching and demonstrate software architecture and technology best practices to technical leads and principal engineers
- Prototype solutions - internally and with vendors - to validate ideas, design assumptions and other aspects of a digital health product
- Architect communication interfaces to support a portfolio of patient facing mobile applications or IoT devices and providing input to the end-to-end roadmap, in collaboration with the product management team
- Proactively monitors all product related components and processes to ensure compliance with Standard Operating Procedure (SOP), audit and industry best practices – good to have
- Knowledge of architecture practices and methodologies with at least one of the major cloud providers. Holding a cloud solution architect certificate (e.g., AWS Solution Architect Associate) is a clear asset