Staff Systems Engineer, Laza Medical

Laza Medical, a Shifamed Portfolio Company, is at the forefront of developing state-of-the-art imaging solutions for cardiovascular applications. Our mission is to democratize top-quality cardiovascular imaging using robotics and AI. To learn more about Laza Medical, please visit https://lazamedical.com/.

ABOUT SHIFAMED

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical technology incubator focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

As a Staff Systems Engineer at Laza Medical, you will be responsible for the design, development, and validation of complex systems for our medical robotics platform. This role requires a deep understanding of medical device development, strong knowledge of hardware and software integration, and expertise in requirements management, verification, and validation processes. The successful candidate will collaborate with cross-functional teams to ensure the seamless integration of robotic technologies into the healthcare ecosystem. This is a full time on-site position and will require reporting to our offices located in Campbell, CA.

Responsibilities, Skills & Hands-On Experience

• Systems Design and Architecture:

• Lead the design and architecture of the medical robotics system, ensuring compliance with regulatory requirements and industry standards.

• Collaborate with hardware and software teams to develop integrated solutions that meet performance, safety, and reliability requirements.

• Requirements Management:

• Define and manage system requirements, ensuring traceability from high-level specifications to detailed subsystems.

• Work closely with stakeholders to gather, document, and prioritize system requirements.

• Verification and Validation:

• Develop and execute comprehensive verification and validation plans for the medical robotics system.

• Conduct testing and analysis to ensure that the system meets all performance, safety, and regulatory requirements.

• Hardware and Software Integration:

• Oversee the integration of hardware and software components, addressing challenges related to interoperability and performance optimization.

• Collaborate with multidisciplinary teams to troubleshoot and resolve integration issues.

• Regulatory Compliance:

• Stay abreast of relevant regulations and standards in the medical device industry.

• Ensure that the medical robotics system is designed and tested in accordance with regulatory requirements.

• Collaboration and Leadership:

• Collaborate with cross-functional teams, including mechanical engineers, software developers, and quality assurance professionals.

• Provide technical leadership and mentorship to junior engineers within the systems engineering team.

Education & Work Experience

• Bachelor's or Master's degree in Systems Engineering, Electrical Engineering, or a related field.

• Proven experience (6+ years) in medical device development, with a focus on systems engineering.

• Strong knowledge of requirements management tools and methodologies.

• Experience with verification and validation processes for medical devices.

• Expertise in hardware and software integration in complex systems.

• Familiarity with regulatory requirements for medical devices (FDA, ISO, etc.).

• Experience in IEC 60601 testing.

• Proficiency in SolidWorks and Onshape.

• Participation in animal and/or clinical testing.

• 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.