Medical Device Software 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 all software engineering at TECLens.  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’ software engineer with significant competence in embedded systems and Windows Embedded OS, software migration, firmware architecture, hardware / software interfacing and GUI development
• Strong technical contributor with deep experience in the regulatory frameworks of medical device development, including 21 CFR 820 regulations, and the IEC-62304, IEC-60601 and ISO 14971 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 of the firmware architecture for the integrated interface console
• Design / Lead adaption of existing and additional control software for the integrated qCXL^TM system
• Design / Lead design effort of the controlling software for all testing, measurement and assembly tooling and in-house custom designed machinery
• Collaborate with the treatment planning team to establish a link between planning output and control system operation
• Plan / Lead a systematic and stepwise approach to software risk management,  verification and validation
• Design / Oversee execution of verification and validation tests to confirm that the software-based system functionality meet established specifications and requirements
• Lead and Participate on cross-functional project teams
• Lead and Participate In and Document FMEA of code, designs and procedures
• Develop and Oversee documentation of all software, from high level design documents to code commenting standards 
• 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 software engineering team

 
 
Primary Qualifications:
BSE, MS, or PhD in software or electrical engineering or computer science 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
• Direct and extensive experience with regulatory (FDA) requirements for software design, development, risk management, verification and validation
• Knowledge of and experience with human factors and usability engineering process 
• Competence in C, C++ and MATLAB.  Experience in C#, WPF and CNC G-code desirable
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
• Strong English written and verbal communication skills