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Medical Device Hardware System Engineer (EE)

Description

You are at the front-line of med-tech innovation. You’ll join a top talent, fun, diverse, tight-knit team of experienced professionals who have worked in healthcare and technology across multiple functions. You're part of the engineering team and develop hardware that is at the core of Bloomlife's medical devices.

You own hardware system development, and related test equipment and accessories. You deliver high quality, well tested and well documented hardware systems for Bloomlife medical devices. You own the hardware design process: from the definition of specs and requirements, design and development, definition and execution of test protocols, design verification (internally and with certified test labs) and design transfer to manufacturing. You contribute to continuous integration and testing during the design and development of Bloomlife medical devices. You maintain qualified test equipment and tooling to support design and development activities. You are the primary technical contact for design and engineering houses and our contract manufacturer. You work hand-in-hand with product managers and application engineers to deliver hardware systems that meet user needs and business requirements. You work closely with our firmware and embedded software team to release new sensor hardware+software features. You show creative thinking and proactively come up with ideas and strategies to improve hardware system performance.

Your responsibilities are:

• You architect, design, develop and test all hardware components of Bloomlife's medical devices.
• You design and assemble the tooling (electrical and mechanical) to test, verify and monitor hardware performance.
• You lead hardware design verification and test to applicable standards (e.g., IEC 60601-1, IEC 60601-2).
• You define the necessary quality control tests and procedures to ensure the quality of all hardware systems and equipment during design, development and manufacturing.
• You work in close collaboration with product, software engineering, quality and regulatory teams, with the goal to provide tested, validated, robust and well-documented hardware for securing regulatory clearance (FDA and CE marking) and deployment in products.
• You provide guidance on industry best practices in electrical engineering.

Requirements

You’re a passionate and experienced medical device hardware system engineer (EE), with a track record of taking medical devices through FDA or CE marking, and commercial launch. You specialize in miniaturized devices for biopotential and/or electrophysiological monitoring. You embrace rapid prototyping in the early stage of development, and are able to transition to production quality when time is right. You work fast without compromising on quality. You’re curious. You’re proud of your design, products and how they change people’s lives.

To succeed in this role, it will help to have:

• Background in Electrical Engineering or equivalent through experience
• 5+ year 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 60601-1 and collateral standards
• Experience with wearable devices and mechanical engineering is a plus

Benefits

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.

Bloomlife has 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 life. 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.