Position Description:
Engineering team member responsible for electrical and embedded systems design of medical device components, tooling and experimental set-ups in support of the of development of the TECLens non-invasive refractive correction system.
Compensation:
Competitive, commensurate with experience. Includes ESOP. Details available upon request.
Location and Travel:
- On site, Stamford, Connecticut
- Up to 10% travel to clinical sites for observation / technical support (US, Caribbean, Asia/Pacific)
General Candidate Description:
- Strong ‘generalist’ systems engineer with competence in analog and digital design, electro-mechanical controls, embedded systems, MATLAB, firmware architecture and hardware / software interfacing
- Ultrasound systems experience desirable
- Experience in the regulatory frameworks of medical device development, including 21 CFR 820 regulations, and the IEC-62304, IEC-60601 and ISO 14971 standards
- Strong, reliable team member able to deliver on tight schedule
- Creative problem solver, unafraid to put forth a novel idea
- “Think-first” collaborator able to deliver – and comfortable accepting – appropriate constructive feedback
- Self-starter who is comfortable in small company environment
Background:
TECLens (www.TECLens.com) is developing a completely novel vision correction technology based on quantitative corneal crosslinking, or qCXLTM. The qCXLTM system has 4 primary components:
- A single use disposable therapy delivery device that delivers therapeutic ultraviolet light (UV) and treatment monitoring ultrasound (US)
- A user interface console that houses the controlling computer and the UV and US systems
- A photoactive drug that interacts with the UV to provide the corneal strengthening that results in refractive change
- A computational treatment planning suite (TPS) that calculates an optimized plan for each patient’s specific needs and provides a control point that the US system monitors during the procedure
Each component of the qCXLTM system has been previously tested either in vivo or in vitro. The role of the of the Electrical Engineer is to support all aspects of the integration of the components into a single medical device including design of documentation of ancillary tooling, assembly, test, and measurement systems. The Electrical Engineer will also aid in the transfer of the design to contract manufacturing.
Responsibilities:
- Design / Lead design effort of ultrasound systems hardware and firmware architecture
- Design / Lead Team Design of electrical system and embedded controller components for the medical device, subsystems, manufacturing tooling and measurement set-ups
- Plan / Lead a systematic and stepwise approach to software risk management, verification and validation
- Collaborate with Principal Software Engineer to develop, test and debug system hardware, firmware and embedded computer controls
- Develop / Execute / Document test and verification procedures for software and electronic components of the disposable device and control system
- Support IQ/OQ/PQ activities for all manufacturing and test equipment
- Develop and Oversee documentation of all software, from high level design documents to code commenting standards
- Lead and Participate on cross-functional project teams
- Lead and Participate In and Document FMEA of code, designs and procedures
- Support transfer of electronic subsystems of medical device to a contract manufacturer
- Support pre-clinical and clinical studies on-site to address any technical needs
Primary Qualifications:
BSE, MS, or PhD in Electrical / Computer Engineering with 5+ years’ experience in medical devices
Additional Qualifications:
- Competence in C++ and MATLAB, with CNC G-code C# desirable
- Expertise in PCB layout software such as KiCad, OrCAD, etc.
- Expertise in electrical circuit design for electromagnetic compatibility (EMC) as well as EMC testing and mitigation techniques
- Proven experience with circuit design for both analog/digital signals and AC/DC power distribution
- Knowledge of and experience with human factors and usability engineering process
- Experience with ultrasound systems desirable
- Very proficient with standard lab equipment (oscilloscope, network analyzer, impedance analyzer, digital multimeter, etc.)
- Understanding of, and direct experience with, regulatory requirement and standards for medical device hardware and software design, development, verification and validation
- Comfortable supporting in vitro and in vivo animal studies
- Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
- Strong English written and verbal communication skill
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