Manufacturing Engineer Jobs

Location – Palo Alto, CA

C Light Technologies is looking for a Manufacturing Engineer to work within a regulated quality system environment to oversee and improve manufacturing processes to produce medical devices.

About C Light Technologies:

C. Light is a healthtech startup company on a mission to create AI-enabled digital tools & solutions to assess eye and brain health for early detection and earlier intervention. Our product, Retitrack, is the first FDA-cleared retinal-tracking oculometer. Our team is actively conducting NIH-funded research to validate AI algorithms on disease predictions, such as Multiple Sclerosis, Alzheimer, mTBI, Parkinson, which can influence hundreds of millions of people worldwide.

We will be using everything we learn from eye tracking data to expand our AI platform across different disease prognostics, early predictions. To deliver on our mission, we need to expand our team with highly skilled and motivated team members to help us change healthcare for the better!

What We Will Need To See:

• Strong hands-on build and trouble-shoot skills.
• Bachelor's degree in Hardware Engineering (ME/EE) or related field required.
• Advanced knowledge of CAD software, SolidWorks preferred.
• Occasional travel (<15%) may be required for device installation, servicing.
• Ability to work well under delivery pressure to meet deadlines in a cross-functional team environment.
• Minimum 3+ years of experience in medical device industry required.
• Capability to interpret and draft an extensive variety of technical instructions, material and device specification documentations.
• Ability to work independently with minimal supervision on a daily basis.

How To Stand Out:

• Strong collaborative and interpersonal skills
• Experience with Quality (IQ/OQ/PQ) and Regulatory requirements such as ISO 13485, ISO 14971, IEC 62304, 21 CFR 820.30 compliance is a plus
• Has knowledge of commonly used concepts, practices and standard operation procedures (SOP) within the Medical Device or related industry.
• Understanding of various production processes (e.g., injection molding, machining, additive manufacturing)
• Experience in supplier interaction, parts procurement, parts receiving and BOM management and maintenance.

Who We Are:

Working for C Light Technologies offers you the opportunity to:

• Tackle complex challenges and projects with the highest levels of quality and execution for audiences that include top technologists, FDA and world-leading healthcare providers
• Work with world-renowned neuroscientists, innovators in the AI technology community in Silicon Valley, recognized leaders of medical doctors and clinicians. Together we are pushing the limits of Artificial Intelligence in the medical space
• Push the accessibility and quality of healthcare to new heights to improve the lives of hundreds of millions of people
• Contribute to a rapidly growing startup that lives by its mission to deliver “Accessible AI Technology”

Who You Are:

Our team structure is pretty flat right now, this position reports directly to CTO for the moment. Once the team scales up report line may change. This role collaborates with teams across the organization including Engineering, Product, Regulatory, Sales and Marketing. As a member of our Engineering team, you will work on :

• Develop and validate test methods to ensure product quality.
• Design and implement fixtures and other manufacturing processing aids.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Participate in design reviews and provide feedback on manufacturing feasibility.
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
• Develop KPIs and report manufacturing performance metrics.
• Work with Quality and suppliers to address nonconformances, CAPAs and SCARs.
• Prepares engineering change orders (ECO) and coordinates the deployment of changes.
• Provide engineering support to device installation, servicing and training to the manufacturing line.
• Improve manufacturing process instructions, work-flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.

What We Believe:

We believe that transforming healthcare solution world will be a defining contribution of our generation to provide broader accessibility, better quality of healthcare service to the people. We have the funding and scale, but we need your help on our team. We believe that inclusion and equity in healthcare start with a community of collaborators that celebrates human differences including race, ethnicity, gender, age, sexual orientation, human need, veteran status, political affiliation, and religion. We value what makes each person unique and create a place for everyone to thrive as we build towards shared goals. We’re committed to continuous learning and are striving to create a principled workplace while continuing to impact the world around us.

If this sounds like you, then apply to be our next Manufacturing Engineer!

C Light Technologies offers competitive salaries with demonstrated experience. Employee benefits include:

• Nice startup working environment and culture
• Lunch perks
• Premium Medical, Dental and Vision Plan
• Free cool developer swags
• Paid vacations and holidays
• 401K plan

C Light Technologies is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.