Nanobiosym is an innovative nanotechnology Company in Cambridge, MA, that is developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine.
Nanobiosym is currently seeking talented electrical engineers with device instrumentation experience.
This is a hands-on position for an individual capable of creative and systematic product development with minimal supervision.
In this position, you will be responsible for instrument system development projects and provide expertise on hardware design, development, verification, validation, manufacturability, product testing, and production ramp-up. This will include providing input into the development of design concepts to meet system requirements according to Company specifications.
The instrumentation engineer has responsibility for instrument hardware development and transfer to manufacturing for in-vitro (IVD) instruments. This includes developing, documenting, debugging, testing, and releasing to manufacturing the electronics used in medical devices. The right candidate for this position will be an experienced engineer with demonstrated success conceptualizing and defining requirements to drive the release of devices to the field. The right candidate should be familiar with Design Control for Medical Devices and other devices and is able to translate product needs into engineering requirements, allocate system level requirements into subsystem level requirements, and ensure complete traceability.
Analysis of analog, digital, and power circuits in existing designs and select and source production-appropriate components as needed.
Creation and maintenance traceability among design input, design output, verification, and validation and risk management artifacts to ensure completeness and fully traceable design history file.
Ability to write verification and validation plans and protocols to effectively test designs against requirements.
In depth knowledge of regulatory procedures that affect methods and techniques to solve issues when creating designs.
Proficiency with medical device regulations (ISO 13485, ISO 14971, 21 CFR part 820.30-Design Controls).
Proficiency with electrical test equipment; oscilloscopes, logic analyzers, etc.
Strong schematic capture skills and good working knowledge of PCB layout software.
Experience in analog and digital circuit design including signal processing, a/d, d/a, power, and firmware design in C.
Proficiency in analog and digital circuit design including signal processing, a/d, d/a, power, and firmware design in C.