Medical Device Mechanical 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 mechanical 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’ engineer with competence in mechanical design, an understanding of electrical and optical systems, familiarity with embedded systems
• Experience in medical device engineering with working knowledge of 21 CFR 820 design 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 Mechanical 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 Mechanical Engineer will also aid in the transfer of the design to contract manufacturing.
Responsibilities:

• Design / Contribute to Team Design of system components, subsystems, fixturing, assembly tooling and test set-ups
• Design / Execute / Document assembly procedures for the disposable therapy delivery device and control system
• Develop / Execute / Document test and verification procedures for disposable device and control system
• Develop / Execute / Document in vitro verifications of test and measurement systems
• Participate on cross-functional project teams
• Participate In and Document FMEA of designs and procedures
• Maintain calibration and qualification of measurement and manufacturing systems per established procedures
• Support transfer of control system, disposable components and packaging 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 mechanical engineering with 5+ years’ experience in medical devices
Additional Qualifications:

• Expertise in SolidWorks
• Competence in MATLAB, CNC G-code, and PCB layout software such as KiCad desirable
• Understanding of and direct experience with standard medical device manufacturing techniques such as injection modeling, thermoforming, adhesive application, printed circuit board (PCB) layout and design, etc.
• Knowledge in design for manufacturing principles for subtractive and additive machining and molded parts
• Understanding of, and direct experience with, regulatory (FDA) requirements for hardware and software design, development, verification and validation
• Comfortable supporting in vitro and in vivo animal studies; familiarity with tissue lab, cadaver lab, and animal lab operations and procedures desirable
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
• Strong English written and verbal communication skill