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About the Role
We are seeking a highly skilled Medical Device Hardware System Engineer to join our team at Bloomlife. As a key member of our engineering team, you will be responsible for developing hardware systems that are at the core of our medical devices.
Key Responsibilities
- Architect, design, develop, and test all hardware components of Bloomlife's medical devices.
- Design and assemble tooling (electrical and mechanical) to test, verify, and monitor hardware performance.
- Lead hardware design verification and testing to applicable standards (e.g., IEC, IEC ).
- Define quality control tests and procedures to ensure the quality of all hardware systems and equipment during design, development, and manufacturing.
- Collaborate with product, software engineering, quality, and regulatory teams to provide tested, validated, robust, and well-documented hardware for securing regulatory clearance (FDA and CE marking) and deployment in products.
- Provide guidance on industry best practices in electrical engineering.
Requirements
To succeed in this role, you should have:
- Background in Electrical Engineering or equivalent through experience.
- 5+ years of experience in medical device hardware electrical engineering.
- Experience with devices for electrophysiological monitoring (e.g., ECG, EEG, EOG, EXG).
- Proven track record in getting medical devices through FDA or CE marking and launching medical products.
- Experience with IEC and collateral standards.
- Experience with wearable devices and mechanical engineering is a plus.
About Bloomlife
Bloomlife is a mission-driven company solving one of the most significant yet underserved challenges today, maternal and neonatal health. We are designing the future of prenatal care to improve the health of moms and babies, through the most advanced combination of technology, medical expertise, and data science. We seek to empower moms to have the healthiest pregnancy possible. We want to eradicate preterm birth and stillbirth. We want to deliver our solutions globally and ensure every baby gets a healthy start.
We have been recognized for our vision to rethink prenatal care and impact the lives of families globally, including winning Richard Branson's Extreme Tech Challenge, J&J Quickfire Challenge Winner, MedTech Innovator Award, Best Health Startup LAUNCH 2016, Ideas from Europe Finalist, CLIO Award Finalist, and speaking at the White House Precision Public Health Summit.
You will join a young, dynamic, and international team who's passionate about using technologies for a better living. You are an early member of a growing start-up with recent successes, and get to experience first-hand the excitement of start-up life. Your work will be highly visible to company founders, directly shape our products, and impact people's lives. We offer a flexible work environment, remote work culture, and a compensation package combining salary and stock options. We have teams in San Francisco, Liege (Belgium), Genk (Belgium), and Eindhoven (The Netherlands). This position can be on-site or fully remote.
