Sr. R&D Engineer - Injectors, Atia Vision

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 Senior R&D Engineer contributes to medical device product design, testing and process development 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 position reports to the Director of R&D. 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

• Apply engineering knowledge and medical device design experience to the design and development of new devices used to implant intraocular lenses in the eye through a small incision.

• Plan, evaluate and implement product changes and enhancements which meet company strategic and quality product development goals.

• Develop product specifications, acceptance criteria, test methods and test protocols / reports to support new product characterization.

• Contribute to Risk Management activities.

• 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.

• Work within house equipment and outside vendors to develop prototypes and designs; maintain accurate documentation of concepts, designs, drawings, and processes.

• Establish relationships with and understand capabilities of component suppliers.

• 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 a clinical need 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.

• Prototyping

• Evaluate, verify, and validate product designs through bench, in-vitro, and in-vivo testing. Generate written reports.

• Develop testing strategies, physical and simulated models, and equipment as needed. Design and produce test fixtures as necessary.

• Create assembly instructions and design and produce fixtures for product assembly and inspection.

• Develop and validate new test methods for product qualification testing.

• Train technicians and assemblers on product assembly; troubleshoot assembly process issues as necessary.

• Project-management

• Support the design and development team in terms of project-management.

• Work within cross-functional teams.

• 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 and 5+ years of previous medical device experience. In lieu of a degree, a demonstrated high level of medical device technical aptitude may be considered.

• Understanding and exposure to principles of product design, design control, risk analysis, and product testing/reporting.

• Proficient with complex mechanical designs used in the implantation of medical devices.

• Working knowledge of polymer science and complex, high precision plastic part manufacturing techniques (molding, 3D printing, etc.) and coatings.

• Working knowledge of CAD design, analysis, and documentation software; Solidworks preferred.

• Familiar with simulation tools such as FEA.

• Experienced with gathering input from multiple sources, especially surgeons and staff, to guide the design and validation testing of ergonomically-sound medical devices.

• Familiar with human factor engineering principles and associated testing.

• Proficient with project management tools.

• Proficient with technical writing of experimental findings and testing instructions.

• Proficient with document control requirements for medical devices.

• Familiarity with FDA QSR, ISO 13485, and the MDD.

• Excellent communication skills; ability to work independently or in project team setting.

• Ability and willingness 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.