Medical Device Electrical Engineer
 
Company:
TECLens is a small medical technology company with an entrepreneurial mindset and culture.  We dream up and invent transformational solutions to vision care challenges facing hundreds of millions of people.  We are looking for highly skilled, motivated, creative and dependable contributors to join our team.
 
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.  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’ electrical engineer with competence in analog and digital design, electro-mechanical controls and embedded systems
• Experience in medical device engineering with working knowledge of 21 CFR 820 regulations and the 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 qCXL^TM.  The qCXL^TM 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 qCXL^TM 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 / Contribute to Team Design of electrical system and embedded controller components for the medical device, subsystems, manufacturing tooling and measurement set-ups
• Develop / Collaborate with Software Engineers to develop, test and debug system firmware and embedded computer controls 
• Develop / Execute / Document test and verification procedures for electronic components of the disposable device and control system
• Support IQ/OQ/PQ activities for all manufacturing and test equipment
• Create written specifications and functional description documents for designs
• Participate on cross-functional project teams
• Participate In and Document FMEA of 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 real-time technical needs

Primary Qualifications:
BSE, MS, or PhD in Electrical Engineering with 5+ years’ experience in medical devices
Additional Qualifications:

• 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
• Competence in MATLAB, CNC G-code, C++ desirable
• 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