Adona Medical a Shifamed Portfolio Companyis focused on innovating interventional approaches for heart failure a complex and progressive failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally. To learn more about Adona Medical please visit 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 This position will play an important technical role in developing a new catheterbased delivery device used to deploy an implant to treat heart failure. The senior catheter engineer will be expected to work as a key member of a team that quickly conceptualizes and develops new designs. The successful candidate must be capable of applying scientific rigor in analyzing and characterizing new designs and providing solutions that create a robust device capable of being used in clinical studies and for commercial sales. They must excel in a highenergy team environment and be capable of making sound decisions when faced with time pressures and incomplete information typical of new product development. This is a full time onsite position and will require reporting to our offices located in Los Gatos CA. Responsibilities Skills & HandsOn Experience - Primarily responsible for design and development of delivery systems subsystems and housings for deployment of a cardiac implant
- Strength in catheter designs including experience with braiding laminating coiling steering and lasercut components
- Rapid prototype design build test and iterate concepts under development
- Support animal model and SimUse bench testing
- Design for cost and manufacturability
- Generation of formal design documentation review and control (e.g. design reviews ECOs mechanical drawings etc.
- Project planning and management for aspects of the system under the engineers authority
- Vendor selection and management
- Manufacturing transition and support
- Develop and author test methods protocols and reports used for evaluation of prototypes and product performance.
- Research and recommend test equipment and design tools.
- Run machine shop/lab equipment necessary for prototyping.
- Collaborate in the evaluation and assessment of competitive products processes or new trends.
- Ensure compliance with all local state federal and safety regulations policies and procedures.
- Participate in and present at department level meetings and projects.
Education & Work Experience - Bachelor of Science in Mechanical Engineering Biomedical Engineering or Material Science.
- Advance degree preferred masters degree in ME or PhD.
- At least five 5 years experience in disposable catheter design and familiarity with commonly used materials and assembly processes.
- Experience working with devices used in Cardiac anatomy atrial anatomy preferred.
- Proficient in SolidWorks.
- Experience with design excellence and rapid product development.
- Passion for creating robust and reliable products.
- Experience leading small engineering teams and mentoring other engineers and technicians.
- Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a strong plus.
- Demonstrated history of products reaching the marketplace.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your jobrelated 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 fulltime position is between $90000 to $180000 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
| Required Experience:
Senior IC