Job description
Adona Medical, a Shifamed Portfolio Company, is focused on innovating interventional approaches for heart failure, a complex and progressive condition. Heart failure is a progressive condition that impacts approximately 6.5 million patients in the United States and as many as 26 million patients globally.
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.
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 system that treats heart failure. 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 hands-on engineer who is a creative thinker, problem-solver, collaborative team player and active in their approach to concept generation and execution. This position represents an exciting opportunity to join the Adona team in its early stage and help us develop a product from the proof-of-concept stage through to clinical use.
This position will play an important technical role in developing a new system that treats heart failure. 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 hands-on engineer who is a creative thinker, problem-solver, collaborative team player and active in their approach to concept generation and execution. This position represents an exciting opportunity to join the Adona team in its early stage and help us develop a product from the proof-of-concept stage through to clinical use.
Responsibilities, Skills & Hands-On Experience
- Mechanical, thermal, and electromagnetic analysis and test of electromechanical medical devices
- System integration of electrical and mechanical aspects of the design for various sub-systems
- Design and development of enclosures for electrical components
- Test method development for both characterization testing and verification/validation testing
- Working with external vendors on component design and manufacturing
- Specification development
- Hands-on prototyping and development of device, processes, and tests
- Work as part of a cross-functional 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
- Support pre-clinical and clinical studies
- Participate in, and present at, periodic department level meetings
- Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice
- Train operators and technicians on product assembly; troubleshoot assembly process issues
- Use of electronics test equipment such as oscilloscopes and DVMs
- Familiarity with hand soldering and wiring practices
- Design and construction bench test systems
- Basic machine shop skills (manual lathe, mill, drill press, hand tools)
- Familiarity with Microsoft Excel for data analysis and/or Matlab
- Some experience programming in Python, Matlab/Octave, LabView, or other high-level application language
- Strong verbal and written communications skills
- Proficient in CAD design software
- Rapid prototyping using 3D printing
- Experience in designing and making test and process fixtures and equipment
- Experience working in a lab and CER
- Excellent communication skills, ability to work both independently and in project team setting
- Basic circuit design
Preferred Skills & Hands-On Experience
- SOLIDWORKS
- Altium or other PCB layout tool
- Signal processing concepts
- Embedded systems and firmware development
- Electromagnetic, resonate charging and RF concepts
- Experience in IEC 60601 Standards and Testing
- Experience in materials and processing; preferably used in cardiovascular and/or structural heart applications
- Project planning and management for aspects of the system under engineer’s authority
- Experience leading small engineering teams and mentoring other engineers
- Vendor selection and management
- Demonstrated history of successful clinical product launch
- Interact with physicians regarding product development, testing, and product demonstrations
- Participation in pre-clinical and/or clinical testing
- Knowledgeable about medical device regulations, ISO requirements and GMP guidelines
Education & Work Experience
- BS in EE, ME, biomedical engineering, or a related discipline
- Experience with design and test of FDA class III medical devices
- 12+ years work experience, including equivalent academic lab experience
- Preferred: Advanced degree in a technical discipline
- Experience in a venture-funded startup environment
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.
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