Engineering · Full-time · Chicago, United States
This role is based in our Chicago, IL office and will be expected to be in office 3 days a week.
SimBioSys is a TechBio company deploying a combination of artificial intelligence, data science, and spatial biophysics to redefine precision medicine, transform patient care, and defeat cancer. By seeing cancer more completely, SimBioSys aims to empower clinicians, patients, and researchers with a more informed understanding of a patient’s tumor to optimally assess all available options and deliver on the promise of truly individualized patient care.
SimBioSys is seeking an experienced Senior Software Engineer to join the team. As a part of the Software engineering team, you will be responsible for contributing to a team of software engineers in the development of advanced AI – Driven surgical planning tool.
At SimBioSys we strive to build an open, inclusive, and diverse workplace. We celebrate what makes each of us unique and pride ourselves on growing as a team. We promote collaboration, accountability, and shared learning to best serve each other and our respective communities. We are proud to be an Equal Opportunity Employer.
General Qualifications:
Responsibilities:
Software Development: Design, develop, and maintain software applications for medical devices, adhering to industry best practices and regulatory requirements. This includes embedded software, user interfaces, and backend systems.
Requirements Analysis: Collaborate with stakeholders to gather and analyze software requirements, ensuring alignment with product specifications, user needs, and regulatory standards such as ISO 13485 and FDA guidelines.
System Architecture: Contribute to the design and architecture of medical device software systems, considering factors such as performance, scalability, reliability, and security.
Regulatory Compliance: Work closely with regulatory affairs teams to ensure software development processes comply with relevant regulations and standards, supporting the preparation of regulatory submissions and audits.
Risk Management: Identify and mitigate software-related risks throughout the product lifecycle, applying risk management techniques such as FMEA (Failure Modes and Effects Analysis) and ensuring traceability of risk controls.
Collaboration: Collaborate effectively with cross-functional teams, including quality assurance specialists, scientists, regulatory and quality, and product managers, to deliver integrated and compliant software solutions.
Continuous Improvement: Stay updated on emerging technologies, industry trends, and regulatory developments relevant to medical device software engineering. Proactively identify opportunities for process improvement and innovation.
About the Candidate: