Job Description: The Senior Hardware Engineer will lead and contribute to multiple concurrent projects for the design, testing, and compliance strategy of the hardware components of the first-in-human (FIH) Our client device. Projects and responsibilities will include:
• Establishing specifications, designing circuit schematics, and creating PCB layouts in Altium.
• Participating in design reviews
• Component management and part sourcing
• Ensuring RoHS and UL compliance of components and suppliers
• Bringing electrical components and designs into IPC class 3 compliance
• Incoming inspection and functional testing of hardware components
• Design and construction of test fixtures and equipment
• Maintaining manufacturing and testing equipment
• Performance of V&V tests on hardware components
• Prepping test articles for external FCC compliance and V&V testing
• Utilizing existing or establishing new Our clients’ strategic partners in manufacturing or other relevant fields to progress from benchtop prototyping to small-scale production.
• Documenting all engineering progress, testing design, and results for quality management.
• Reporting engineering updates and other progress to upper management monthly and other engineers on a weekly basis.
Skills and Requirements:
• Bachelor’s degree in electrical engineering or equivalent engineering discipline.
• Master’s degree in electrical engineering or equivalent work experience.
• Altium or other equivalent ECAD software experience.
• Experience with Quality Management Systems and familiarity with FDA and ISO regulations.
• Ability to be agile in a rapidly evolving engineering workplace.
• Strong technical writing and documentation skills.
• Ability to problem solve and develop creative solutions both independently and collaboratively