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.
Since launching the BrightInsight Platform in 2018, we have secured a number of top-tier customers, including announcements with 4 of the world’s top 20 biopharma companies. Our award-winning platform was selected as the “Best IoT Healthcare Platform” in the 2019 MedTech Breakthrough Awards, Google Cloud’s Partner of the Year for Healthcare for two consecutive years, was featured as the cover story for CIOReview Magazine’s “20 Most Promising Biotech Solution Providers 2019," and was included in The Journal of mHealth's “2020 Global Digital Health 100”.
If you enjoy working with solution-oriented, driven colleagues in an agile, beaurocratic-free environment, then come join us at BrightInsight.
The Software Engineering Architect 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.
We are looking for someone who thrives in a start-up environment and demonstrates:
- Relentless drive to win and bring a product to market
- Start-up mentality to wear multiple hats and do what’s required to get the job done
- Passionate customer focus
Here is a glimpse of what you’ll do:
- Work with other architects to define, architect, document and lead 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 product team to understand and define customer products use cases and convert these use cases into software requirements and architecture and design implementations.
- Own and lead software development life-cycle, including sub-system architecture and design specifications, SW requirements, unit and integration testing, software FMEA, 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 with 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 medical device software
- Demonstrated applied expertise with Software FMEA process
- Familiarity with Software as a Medical development
- Experience working with nearshore and/or offshore development partners
- Familiarity with health and data privacy regulations
- Up to 30% travel to European locations
- As a part of geographically distributed delivery team off-hours conference calls are common
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.