With over 400M connected medical devices worldwide and the value of thehealthcare Internet of Things (IoT) market valued at $163 billion, it’s no surprise that venture funding in the Digital Health space has hit record highs year after year. What’s clear is that all of healthcare’s future products – medical devices, combination products, wearables, Software as Medical Device and more – will all be digitally driven.

A leader in the digital health space is BrightInsight, the VC-backed Silicon Valley startup that provides the leading global regulated IoT platform for the world’s top biopharma and medtech companies.

We are a team of experienced professionals who have first-hand experience building and scaling digital health solutions within the regulated healthcare space. We are passionate about what we do and wholeheartedly believe in our vision to transform patient outcomes globally by bringing the power of digital technology to healthcare.

If you enjoy working with solution-oriented, driven colleagues in an agile, bureaucratic-free environment, then come join us at BrightInsight.

Position Summary

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. These solutions include mobile, web, and web services that leverage the capabilities of the BrightInsight platform. The BrightInsight platform is a medical IoT, cloud-based platform for the life science industry, and is used to manage, process, and store patient health and medical device data to be used for patient diagnosis and treatment.

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.
• 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

Here is some of what you’ll need (required)…

• 7+ years of hands-on software development experience
• 7+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
• Demonstrated applied expertise in FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, IEC 62366, and IEC 62304
• 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
• Experience in working in an environment following Agile methodology
• Demonstrated applied expertise with Software FMEA process
• Familiarity with SaMD development
• Experience leading nearshore and/or offshore development partners
• Familiarity with health and data privacy regulations

BrightInsight is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. BrightInsight does not discriminate in employment opportunities or practices on the basis of: age, race, religious belief, colour, sex, national origin, marital status, sexual orientation, gender identity, disability, pregnancy status or any other status protected by law. BrightInsight makes reasonable adjustments so that qualified applicants with a disability may participate in the selection process. BrightInsight will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with BrightInsight.