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 Design Quality Engineer will be working with the product, platform, and software engineering team to provide design control and software/systems development guidance. The Senior Design Quality Engineer will be Design Quality Assurance representative in regulated development activities for various software medical devices solutions.

These solutions include cloud-based applications, 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…

  • Active participation in design, development, and deployment activities, working closely with Architects, Engineers, Product Managers, Scrum Masters, and Program Managers.
  • Act as the leader in bringing the culture of quality in software medical device development
  • Participate and lead Risk Management, Design Assurance, Design Verification, Design Reviews, and Reliability Planning activities
  • Assist in the development of SOP's and Work Instructions governing or associated with design control activities/compliance

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

  • 3+ years of hands-on software development experience
  • 5+ years of experience in software medical device development classified as Class 2 and/or Class 3 medical device
  • Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, and IEC 62304
  • Demonstrated applied expertise in writing different design control deliverables for Class 2 and/or Class 3 medical device software
  • Familiarity with SaMD/software-only medical device development
  • Experience working with nearshore and/or offshore development partners
  • Familiarity with health and data privacy regulations
  • Familiarity with the role of Human Factors/Usability in the software development lifecycle 

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