Principal Systems Engineer, Adona Medical

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. To learn more about Adona Medical, please visit https://www.adonamed.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 Principal Systems Engineer contributes to medical device product development, requirement definition and verification and validation testing in accordance with the company's Quality System. Duties include being responsible for integration and testing of systems that include mechanical, electronic, and/or electro-mechanical assemblies. Documentation includes documenting system requirements, writing test methods, test protocols and reports, and recording build/test data. Contributes as an individual contributor and team leader. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.

Responsibilities, Skills & Hands-On Experience

• Support the development of system architecture and design specifications for the Adona system, considering user needs, product requirements, applicable standards, and technical feasibility.

• Define and manage system requirements, ensuring traceability and alignment with product specifications, risk management, and regulatory standards such as 21 CFR 820, MDR, IEC 60601 series, ISO 14708-1/EN 45502 and ISO 13485.

• Conduct risk analysis and mitigation activities in accordance with ISO 14971 standards, identifying and addressing potential hazards with risk mitigation activities.

• Support the development of test methods for verification and validation activities.

• Plan and execute verification and validation activities to ensure that system requirements are met and product performance is validated according to regulatory requirements, managing external test resources when necessary

• Coordinate integration efforts across multidisciplinary teams, overseeing system integration testing and troubleshooting to ensure seamless interoperability of subsystems.

• Collaborate with Quality and Clinical teams to ensure compliance with applicable regulatory standards and guidelines, providing technical documentation and support for regulatory submissions.

• Establish and maintain quality assurance processes and procedures to ensure the reliability, safety, and effectiveness of the Adona system in accordance with ISO 13485 and FDA Quality System Regulation

• Work closely with cross-functional teams including software engineering, electrical engineering, mechanical engineering, quality, and manufacturing to drive product development efforts and resolve technical issues.

• Lead and provide support to quality processes and apply formal problem-solving techniques to determine root cause and implementing solutions to design and manufacturing issues (non-conformance, CAPA, change management, audits, product complaint investigations, etc.).

• Provide technical guidance and mentorship to junior engineers, fostering a culture of innovation, continuous improvement, and adherence to best practices in systems engineering.

Education & Work Experience

• Bachelor's degree in Engineering or related field; advanced degree preferred.

• Minimum of 12+ years of work experience in research and development, preferably in the medical device industry.

• Strong understanding of systems engineering principles, including requirements management, risk management, and verification/validation.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.

• Familiarity with quality management systems and regulatory requirements for medical devices (e.g., ISO 13485, FDA QSR).

• Strong problem-solving skills and attention to detail, with a commitment to delivering high-quality, safe, and reliable medical devices.

• Proficient with SolidWorks or equivalent CAD software.

• Preferred experience with Class 3 medical device development and compliance with regulatory standards such as FDA, ISO, and IEC.

• Preferred experience with assembly, manufacturing, and testing of microelectronics.

• Preferred experience in developing automated test systems, with experience in Labview and programing in Python.

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 $100,000 to $200,000 + 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.