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
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.