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 Systems Engineering Lead will utilize an interdisciplinary approach, focusing on customer needs and requirements, and work closely with the development team to design, develop, document and test various software solutions ranging from medical mobile apps to medical-grade cloud-based systems. This position also helps lead the development team from the ambiguity of voice of customer through verification and validation in order to arrive at the best possible solution in a compliant, high quality, and timely manner. This position is responsible for aspects related to product design, development, and maintenance, with focus on requirements, risk analysis, usability, verification, and validation for digital products running on 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
- 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…
- Leads definition of requirements for software-based medical devices, covering functional and non-functional requirements
- Works closely with product management to interpret customer, business, and compliance needs to define technical requirements
- Identifies essential and critical requirements, and effectively trace requirements to design and test cases
- Learns and understands all the BrightInsight Platform microservices and API interfaces within those microservices in order to effectively trace requirements and design test cases
- Leads strategy and definition of high quality and comprehensive system verification and validation
- Works with customer, product management, and clinical/medical leads to drive risk analysis activities, including risk management planning, hazard analysis, and risk-benefit analysis
- Leads strategy and execution of design reliability
Here is some of what you’ll need (required)…
- 7+ years of software-based medical device systems engineering experience
- Demonstrated applied expertise in 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
- Experience in working in an environment following Agile methodology
- Demonstrated applied expertise with medical device risk analysis process
- Experience leading nearshore and/or offshore development partners
- Experience providing technical leadership
- Experience launching medical device solutions
- 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.