Medical Device Hardware System Engineer: Precision Technology Specialist
6 dagen geleden
Company Overview
Bloomlife is a pioneering force in maternal and neonatal health, harnessing cutting-edge technology to redefine prenatal care. Our mission-driven team seeks passionate professionals to join our dynamic journey.
About the Role
We are seeking a skilled Medical Device Hardware System Engineer to spearhead the development of innovative hardware systems for our medical devices. As a key member of our engineering team, you will be responsible for designing, developing, and testing high-quality hardware components that meet user needs and business requirements.
Your 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 quality control tests and procedures to ensure the quality of all hardware systems and equipment during design, development, and manufacturing.
- Collaborate closely 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. Your specialization in miniaturized devices for biopotential and/or electrophysiological monitoring will be valuable assets in this role.
To succeed in this position, you'll have:
- A background in Electrical Engineering or equivalent experience.
- At least 5 years of experience in medical device hardware electrical engineering.
- Experience with devices for electrophysiological monitoring (e.g., ECG, EEG, EOG, EXG).
- A proven track record in getting medical devices through FDA or CE marking and launching medical products.
- Experience with IEC 60601-1 and collateral standards.
- Possibly wearable devices and mechanical engineering experience.
Benefits
Bloomlife offers a compensation package combining salary ($150,000 - $200,000 per year) and stock options, reflecting your value as an integral part of our team. You'll also enjoy a flexible work environment, remote work culture, and the opportunity to make a meaningful impact in the lives of mothers and babies worldwide. This position can be on-site or fully remote.
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