With over 400M connected medical devices worldwide and the value of the healthcare 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 ttransform 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, bureaucratic-free environment, then come join us at BrightInsight.
The Senior Software Systems Engineer will be working with the product, systems, architects and software engineering team to ensure 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 BrightInsightplatform 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…
- Collaborate with software and systems engineering to transform software-based medical devices requirements into formally documented detailed requirements, design, and development stories
- Work with the Product Managers totrack and maintain the product requirements backlog throughout the project
- Supports System Engineering and Software Engineering to lead daily activities with software development and test team to deliver complex, high-performing, and reliable software solutions
- Manage the day-to-day activities of the software engineering and test engineering teams throughout the software development life-cycle, including sub-system architecture and design specifications, code review, unit and integration testing, software FMEA, static analysis, and vulnerability analysis.
- Work with software architects to create thetraceability of software requirements into software architecture and design specifications all the way down to base software units.
- Work with System engineering to effectively trace requirements to design and test cases and ensure comprehensive system verification and validation
- 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)…
- 3 – 5years of hands-on software development and/or systems engineering experience
- Experience in software medical device development classified as Class 2 and/or Class 3 medical device preferred
- Knowledge of 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 development stories, documenting design specifications, performing code review, static analysis for software-based medical device software
- Experience in working in an environment following Agile methodology
- Experience with Software FMEA process
- Familiarity with SaMD 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, religion, color, sex, national origin, marital status, sexual orientation,
gender identity, veteran status, disability, pregnancy status or any other status protected by law. BrightInsight provides reasonable accommodation 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.