Nanobiosym is an innovative nanotechnology company in Cambridge, MA that is developing point-of-care diagnostics 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.
Production of development plans and schedules, interface specification, device and module level architecture specification, design and test specification, constraints specification, and verified RTL and test code
Design support for printed circuit boards and test fixtures
Design of electronics containing analog, digital, and microcontroller circuitry
Development of performance and test specifications from design requirements
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.
Responsibility for root-cause analysis of instrumentation issues that arise during development and introduction of product
- Electrical Engineering degree
- 4+ years in electrical circuit design, test and product development working under a certified quality system (medical product design preferred)
- Exceptional analytical, fabrication, and troubling shooting skills
- Fundamental knowledge of components and circuits
- Ability to write product, design, and performance specifications
- 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 Solid Modeling tools such as SolidWorks
- Proficiency with electrical test equipment; oscilloscopes, logic analyzers, etc.
- Experience with circuit modeling software such as PSpice
- Strong schematic capture skills and good working knowledge of PCB layout software.
- General experience with PCB development including schematic, layout, building, and debugging
- Experience in analog and digital circuit design including signal processing, a/d, d/a, power, and firmware design in C.
- Proficiency with simulation and testing software such as Labview, MATLAB, and Simulink
- Proficiency in analog and digital circuit design including signal processing, a/d, d/a, power, and firmware design in C.
- Experience with GUI development kits (Android)
- Familiarity with JAVA, Verilog and VHDL
- You are energetic and willing to work hands on in a variety of development activities
- You are methodical, detail oriented, well organized and effective at time management
- You are a self-starter
- You have good interpersonal, verbal communication, and documentation skills
- You can function well in a challenging and fast-paced environment
- You are enthusiastic and positive, with strong skills in the areas of dependability, flexibility, and maturity
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