Staff RD Engineer Adona Medical
Staff RD Engineer Adona Medical
Posted on :
16-03-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 90000 - 180000
Vacancy
1 Vacancy
Posted on :
16-03-2025
Job Description
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 new catheterbased medical device designs. The Staff Engineer will be expected to work as a key member of a team that quickly conceptualizes and develops new designs. The Staff Engineer will play a lead role in the design and development of mechanical systems subsystems and the user interface of disposable medical catheters. They must be capable of creating designs capable of being used in clinical studies and for commercial sales. The successful candidate 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. The Staff Engineer must be capable of leading engineers or technicians through the design and development process. 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.
- Experience with designing and testing of molded handle housings and complex mechanisms.
- Rapid prototype design build test and iterate concepts under development.
- Support animal model and SimUse bench testing.
- Design for cost and manufacturability.
- Project planning and management for aspects of the system under the engineers authority.
- Vendor selection and management.
- Supervise technical staff (engineers technicians and interns).
- Generation of formal design documentation review and control (e.g. design reviews ECOs mechanical drawings etc..
- Manufacturing transition and support.
- Develop and author test methods protocols and reports used for evaluation of prototypes and product performance.
- Concept documentation preparation and review of patent submissions and support for regulatory submissions.
- Perform other duties as assigned.
Preferred Skills & HandsOn Experience
- 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.
- Participate in and present at department level meetings and projects.
- Work with the Regulatory Department to ensure that design specifications for the system meet or exceed all applicable environmental and regulatory standards.
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 seven 7 years experience with mechanism design including medical device design experience.
- Proficient in solid modeling. SolidWorks required.
- Experience designing molded components and assemblies for use in disposable medical devices.
- Experience with design excellence and rapid product development.
- Passion for creating robust and reliable products.
- Demonstrated history of products reaching the marketplace.
- Experience leading small engineering teams and mentoring other engineers.
- Knowledge of ISO requirements and GMP guidelines. Experience with FDA regulations and medical device design control a strong plus.
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:
Staff IC
Employment Type
Full-Time
Key Skills
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