Atia Vision, is a Shifamed Portfolio Company that is committed to improving patient outcomes by developing a safe and controllable presbyopia correcting IOL that aims to restore the full range of functional vision in cataract patients, the largest segment of the ophthalmology market. To learn more about Atia Vision, please visit www.atiavision.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description
The Principal R&D Engineer contributes to medical device product design, development, manufacturing, and testing in accordance with the company’s Quality System. Helps generate design inputs where required through interface with cross-functional team members, physicians, and other caregivers. Contributes both individually and as part of a cross-functional product development team. This is a full time on-site position and will require reporting to our offices located in Campbell, CA.
Responsibilities, Skills & Hands-On Experience
- Design & Development Skills
- Apply engineering knowledge and medical device design experience to the design and development of new products as well as product changes and enhancements which meet company strategic and quality product development goals.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Establish relationships with and understand capabilities of component suppliers.
- Contribute to developing Product Specifications and Risk Assessments.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- May work directly with marketing, physicians, and/or other caregivers to determine product design needs, user interface, and possible integration of product with other medical systems or products.
- May provide user training and contribute to the development of support materials as required.
- Contribute to the intellectual property position of the company via lab notebook documentation, invention disclosures and prototypes to demonstrate reduction to practice. Participate in technical “brainstorming” sessions to generate new intellectual property.
- Curiosity for all things medical. Ability to immerse oneself in clinical literature to better understand clinical needs and then brainstorm on potential solutions.
- Bias toward fully understanding disease state, current procedures, and clinical needs prior to developing solutions.
- Ability to distil brainstorms into ideas, ideas into prototypes, and prototypes into human-ready medical devices.
- Passion for innovation and inventorship.
- Data analysis
- Plan testing strategy and analyze experiment results using statistical rationales.
- Use predictive models based on statistical tools and machine learning.
- Vision Science
- Apply Vision Science principles to the interpretation of clinical study outcomes.
- Drive interpretation of clinical data from output of diagnostic equipment.
- Develop and use a dynamic model for the optical structures of the phakic and pseudophakic eyes to optimize biomedical optics.
- Good laboratory practice, documentation, and reporting
- Train to and utilize required Quality System procedures, including design controls; adhere to Quality Policy
- Communicate clearly in written technical documentation and oral presentations, including slide decks.
- Support company goals and objectives, policies, and procedures, QSR and FDA regulations.
- Perform job functions in a safe and effective manner.
Education & Work Experience
- Bachelor’s in Engineering or in other Scientific fields and 8+ years of previous medical device experience.
- Master of Science or higher degrees preferred.
- Proficient with principles of product design, design control, risk analysis, and product testing/reporting.
- Proficient with Vision Science principles, showing successful implementation in the design and development of medical devices.
- Ability to analyze subjective and objective refractive data in human clinical studies.
- Ability to consider the total optical design system of the phakic eye and the pseudophakic eye and characterize their response dynamically under various environmental conditions.
- Knowledge of how optical and mechanical properties of materials, optical system designs and associated optical aberrations interact with the physiology of the eye.
- Knowledge of methods and instrumentation to dynamically visualize and model the optical structures in the human eye in research and clinical settings.
- Proficiency with statistics to plan experiments and interpret results.
- Familiarity with FDA QSR, ISO 13485, and the MDD.
- Excellent communication skills; ability to work independently or in project team setting.
- Ability to travel.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $90,000 to $180,000 + equity + benefits.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.