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:

• You value integrity and pride yourself on doing the right thing, even when no one is watching

• You are accountable to yourself, your team, and your commitments. You are not afraid to admit when you make mistakes, and you use those opportunities to learn and grow

• You have a proven record of a high say/do ratio, you hold true to your commitments and inspire your team to do the same

• You adapt to each situation quickly and can drive full ownership of your work

• You jump in and you solve problems. You can troubleshoot quickly, but also know the right times to ask for help

• You look for opportunities to make things better and faster (without compromising quality)

• You are compassionate and patient focused. Our company revolves around delivering an exceptional patient experience that will impact individual lives

• You are inquisitive and do not hesitate to ask questions. You seek new opportunities to learn and grow as an individual and as a team

• You are a team player and are capable of empathizing with others. You consider yourself to have an above average “E.Q.”

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:

• Bachelor's or master's degree in computer science, Computer Engineering, or related field

• 8+ years of hands-on experience in the full software development lifecycle, with 3 years in an FDA Regulated software development environment preferred

• Strong technical skills in software development and experience with software development methodologies, software architecture, software design, database design, cloud computing, data analytics, and information security

• Full-stack development experience, particularly using Python, React, and Typescript.

• Demonstrated proficiency in database concepts and developing applications that drive SQL databases.

• Experience with designing cloud- native software solutions using technologies such as Docker and one or more major cloud service providers such as AWS, Azure, or GCP.

• Strong analytical and quantitative skills; ability to make data driven decisions.

• Excellent communication and interpersonal skills, with the ability to communicate complex technical concepts to non-technical stakeholders

• Experience with Agile development methodologies (e.g., Scrum, Kanban) preferred