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 investment 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 pioneer in the digital health space, BrightInsight is a growth stage company backed by leading life sciences and software investors (General Catalyst, Insight Partners, Eclipse and New Leaf Ventures) that provides the leading global regulated IoT platform for the world’s top Biopharma and MedTech companies.

Since launching the BrightInsight Platform in 2018, we have secured a number of top-tier customers, including six of the world’s top 10 biopharma companies and three leading diagnostic companies. Our platform has been honored with some 15 industry awards, including CB Insights Digital Health 150 in 2020 and 2021, Google Partner of the Year, Healthcare and Life Sciences for two consecutive years, and BrightInsight ranked 13 on the LinkedIn Top Startups List in the U.S.

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.

If you enjoy working with passionate, solution-oriented, colleagues in an agile, low bureaucracy environment, then come join us at BrightInsight!

About the Role:

The Staff Software Test Engineer position will be a remote position based out of the EU. The Staff Software Test engineer acts as the lead of the QA team assigned to a particular customer project. The role will work closely with the product, systems, architects, and software engineering teams to ensure customer solutions are properly tested and the associated requirements verified. The Staff Software Test engineer defines the overall test strategy for products. They play a key role in identifying areas where automated testing can be leveraged and provide architectural input in the early stages of development to facilitate this. The developed solutions include 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.

What We’re Looking For:

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…

• Own the software test strategy for their assigned customer project/s.
• Act as the primary interface with customers for testing related topics.
• Identify areas where test automation can be leveraged to gain efficiency and provide architectural input to support this.
• Review and provide input on project requirements to ensure they are sufficient and testable.
• Ensure test cases comprehensively verify the product and associated requirements.
• Act as lead Scrum Master of the QA team assigned to a customer project
• Manage testing timeline, testing scope, manage QA resources (staffing, interviewing, performance monitoring) to ensure product/project quality.
• Review test cases developed by QA resources to ensure they adequately verify the associated requirements and product functionality.
• Review executed test results including evidence when appropriate to ensure quality and compliance with company defined standards.
• Establish test plan, test group, and test cycle organization and ensure QA resources follow the defined organization.
• Triage and prioritize defects identified by the customer.
• Triage and prioritize defects identified by the QA team.
• Help QA resources resolve blockers during test execution.
• Collaborate with Systems Engineering on testing of risk management and security related design controls.
• Review traceability reports and ensure all requirements are covered by test cases.

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

• 8+ years of experience
• 6+ years of hands-on software test experience.
• 2+ years leading teams focused on software testing.
• Experience in software medical device development (FDA Class II/III 62304 Class B/C).
• Experience with test automation frameworks and solutions such as testing, Selenium, Appium, Cucumber, and RestAssured.
• Demonstrated applied expertise in producing test plans/protocols and test reports as components of a medical device design history file (DHF).
• 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.
• Experience in working in an environment following Agile methodology.
• Familiarity with SaMD development.
• Experience working with nearshore and/or offshore development partners.

Here are a few of our preferred experiences:

• Knowledge of non-functional requirements testing methods, including performance, scalability, load, software reliability, cybersecurity, etc.
• Experience with requirements, test, defect management tools
• Experience with Google Cloud Platform and cloud computing and object storage
• Experience with Different types of testing including code inspections, code reviews, static and vulnerability analysis

What We Value:

At our core, we value partnership. We are strategic partners to our customers, and we partner together every day to achieve our vision of transforming patient outcomes globally by bringing the power of digital technology to healthcare.

• Passion about transforming care and patient outcomes
• Accountability to one another, our valued customers and our mission-critical projects
• Respect for one another, our customers and the data that we manage
• Trust in each other and display integrity in everything we do
• Nimble and agile in our work, but without short cuts
• Excellence in the products we deliver and people we hire
• Real world impact – we aim to positively impact healthcare globally by executing every day on our mission of accelerating digital health innovation for our biopharma and MedTech customers

What You’ll Love About Us:

• Competitive salary and bonus plan
• Equity in the company
• Full range of medical, dental, vision benefits
• Supplemental maternity/paternity time off policy
• 401K match
• Life insurance/ADD/STD/LTD
• Paid Monthly Mental Health Days Off

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.