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 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, bureaucratic-free environment, then come join us at BrightInsight.
The Sr. Quality Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for collaborating with Engineering, Operations, and other functional groups to ensure quality performance of 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 will do…
- Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
- Investigate product quality problems and determine root cause, and implement corrective actions to reduce or eliminate cause
- Lead the resolution of quality issues related to non-conformance reports and CAPAs
- Participate in the development and improvement of the manufacturing processes for existing and new products.
- Support supplier management activities.
- Analyze data, to determine trends, as part of continuous improvement activities.
- Develop an understanding of change and risk management practices and concepts with the ability to become proficient in process risk.
- Assist with the notified body and regulatory authority audits and inspections.
- Other duties/ activities may be necessary to support departmental or company goals
Here is some of what you will need (required)…
- A minimum of 7 years quality assurance/engineering experience is required. Experience in a regulated industry (medical device)
- BS degree in Engineering or Lifesciences
- Experience with FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971)
- Experience with non-conformances, CAPA, and Risk Management
- Extensive experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)
- Familiarity with SaMD/software-only medical device development
- 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, color, 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.