Medical Device Design Engineer and Team Leader
 
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:
Lead the engineering design and integration of the TECLens non-invasive refractive correction system.  Must be a team leader and an individual contributor.
 
Compensation:
Competitive, commensurate with experience.  Details available upon request.
Location and Travel:

• On site, Stamford, Connecticut
• 10% to 20% travel to clinical sites for observation / technical support (US, Caribbean, Asia/Pacific)

General Candidate Description:

• Collaborative team leader and mentor
• Well-rounded ‘generalist’ engineer with competence in mechanical and electrical design, hardware / software interfacing and embedded systems
• Strong technical contributor with deep experience in the engineering and regulatory frameworks of medical device development including the 21 CFR 820 regulations, and the IEC-60601, IEC-62304, ISO 14971 and ISO 13485 standards
• Very capable manager able to prioritize and delegate appropriately to deliver on tight schedules
• Creative problem solver, unafraid to put forth a novel idea
• “Think-first” leader 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 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 Engineer Team Leader is to lead the system integration of the components into a single medical device and oversee transfer of manufacturing of the disposable component to a contract manufacturing organization.  Reporting team will include FTEs with electrical, mechanical and software engineering experience.
Responsibilities:

• Design / Lead design effort for internal architecture of integrated interface console with consideration to reliability, serviceability and compatibility within the medical environment (e.g. electromagnetic interference emission, EMI)
• Design / Lead adaption of existing and additional control software for the integrated qCXL^TM system
• Plan a systematic and stepwise approach to system integration and verification
• Collaborate with the treatment planning team, the quality and regulatory team and the COO to implement the integration plan
• Lead and Participate on cross-functional project teams
• Lead and Participate In and Document FMEA of designs and procedures
• Design / Oversee testing and documentation of assembly tooling and procedures for the disposable therapy delivery device
• Establish / Oversee Execution of procedures for verification and continued qualification of all measurement and manufacturing systems 
• Design / Oversee execution of verification tests to confirm that the disposable, console and software designs meet established specifications
• Oversee transfer of control system, disposable components and packaging to a contract manufacturer
• Support pre-clinical and clinical studies on-site to collect use-case feedback and address any real-time technical needs
• Develop / Implement a continuous improvement plan that utilizes physician feedback and clinical results to enhance performance, reliability and the physician and patient experiences
• Lead, Manage, Mentor and Coach junior members of the engineering team

 
Primary Qualifications:
BSE, MS, or PhD in electrical or mechanical engineering with 10+ years’ experience in medical devices
Additional Qualifications:

• Demonstrated ability in project /program management
• Experience leading teams and managing team members to achieve established goals
• Understanding of and direct experience with regulatory (FDA) requirements for hardware and software design, development, verification and validation
• 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, dimensioning/tolerancing, etc. for subtractive and additive machining and molded parts
• Knowledge of and experience with human factors and usability engineering process 
• Understanding of IQ/OQ/PQ practices
• Competence in SolidWorks, MATLAB, CNC G-code, and PCB layout software such as KiCad
• Capable of conducting patent and competitive product research on the internet
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
• Strong English written and verbal communication skills