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 electromechanical implant used to treat heart failure. The Principal Implant R&D Engineer will work as a key member of a team that quickly conceptualizes and develops new designs develops and optimizes manufacturing processes and conducts verification & validation testing. 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. We are currently looking for a handson engineer who is a creative thinker problemsolver collaborative team player and active in their approach to concept generation and . This position represents an exciting opportunity to join the Adona team in its early stage and help us advance our flagship product from design freeze into clinical launch. 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 supporting the design and development of implant systems subsystems and assembly procedures for the active cardiovascular implant.
- Handson prototyping and development of device processes and tests.
- Work as part of a crossfunctional team to develop and evaluate product designs through verification and validation testing.
- Prepare technical documentation including manufacturing instructions test methods protocols and reports to support design control activities and regulatory submissions.
- Participate in and present at periodic department level meetings.
- Contribute to the companys intellectual property via invention disclosures brainstorming sessions and prototypes to demonstrate reduction to practice.
- Mentor and direct other Engineers in product development and design verification testing.
- Experience in implant design materials and processing; preferably used in structural heart or cardiovascular applications.
- Handson prototype manufacturing.
- Proficient in CAD design and documentation software; SolidWorks preferred.
- Basic hand tool operation.
- Excellent communication skills; ability to work both independently and in project team setting.
- Knowledgeable about medical device regulations ISO requirements and GMP guidelines.
- Design verification testing.
- Project planning and management.
- Experience leading small engineering teams and mentoring other engineers.
- Experience working in a lab and CER.
Preferred Skills & HandsOn Experience - Experience with Nitinol preferred.
- Experience with implantable coatings membranes and/or fabric technologies preferred.
- Experience in designing and making test and process fixtures and equipment.
- Basic machine shop skills.
- Vendor selection and management.
- Demonstrated history of successful clinical product launch.
Education & Work Experience - BS in ME or BME Masters Degree preferred
- 12 years work experience.
- Preferred:
- 3 years in implantable medical device design.
- Experience in a venturefunded startup environment.
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