Medical Device Hardware System Engineer
3 weken geleden
About Bloomlife
Bloomlife is a mission-driven company dedicated to improving maternal and neonatal health through innovative technology and medical expertise. Our goal is to empower mothers to have the healthiest pregnancy possible and eradicate preterm birth and stillbirth.
Job Summary
We are seeking an experienced Medical Device Hardware System Engineer to join our team. As a key member of our engineering team, you will be responsible for developing high-quality, well-tested, and well-documented hardware systems for our medical devices.
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 test to applicable standards (e.g., IEC 60601-1, IEC 60601-2).
- Define necessary 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
We're looking for 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 should specialize in miniaturized devices for biopotential and/or electrophysiological monitoring. Experience with wearable devices and mechanical engineering is a plus.
What We Offer
Bloomlife offers 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.
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