SimBioSys, Inc. · 5 hours ago
Sr. Software Engineer (Consultant)
United States
Contract
Remote
Senior Level, Lead/Staff
$70/hr - $100/hr
8+ years exp
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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.
Qualification
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Required
Bachelor's degree or master's degree in Computer Science, Computer Engineering, or related field
8+ years of hands-on experience in the full software development lifecycle
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
Preferred
3 years in an FDA Regulated software development environment
Experience with Agile development methodologies (e.g., Scrum, Kanban)
REST: 1 year
Java: 1 year
Benefits
1099 contract
Hourly pay
Company
SimBioSys, Inc.
SimBioSys is a pioneering TechBio company leveraging artificial intelligence and biophysical modeling to harness the power of spatial biophysics to redefine precision medicine, transform patient care and defeat cancer.
11-50 employees
H1B Sponsorship
SimBioSys, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Early StageTotal Funding
$15M2021-10-26Series A· $15M
Leadership Team
Joseph R. Peterson
CTO & Cofounder
Barry Rosen
CMO
Recent News
Medical Product Outsourcing
2024-04-14
Company data provided by crunchbase
