United States onlyLocation – Chicago, IL | Coralville, IA | or Remote-US
Digital Diagnostics is looking for a Process Software Engineer with a strong focus on quality and processes to join our engineering team. The ideal candidate will have experience in developing software medical devices and a deep understanding of industry standards such as IEC 62304, ISO 13485, and ISO 14971. This role involves developing and maintaining procedures, assisting the engineering team with adoption and training, and ensuring our products meet the highest quality standards.
Key Responsibilities:
- Develop, implement, and maintain software development life cycle (SDLC) procedures to align with industry standards. Provide training and support to the product development team on quality processes and best practices.
- Stay updated on the latest industry trends, regulations, and best practices related to medical device software development. Collaborate with cross-functional teams to ensure compliance.
- Participate in the design and development of software for medical devices, ensuring all quality and process requirements are met. Assist in the creation and maintenance of technical documentation, including risk management files and software verification and validation plans.
- Support regular audits and reviews of software development processes to identify areas for improvement. Support the continuous improvement of our software development processes to enhance product quality and reliability.
What You’ll Bring to the Team
- Bachelor’s degree or equivalent experience in Computer Science, Software Engineering, or a related life science, technical, or healthcare discipline.
- Strong knowledge of medical device quality systems and regulation like 21 CFR 820 and standards like IEC 62304, ISO 13485, and ISO 14971.
- Minimum 5 years in the medical device industry with at least 3 years supporting software development for medical devices.
- Experience with common SDLC processes (e.g. agile, waterfall, etc.) and quality assurance practice understanding, at least 1 year supporting audits (external/internal).
- Collaborative and detail-oriented with strong problem-solving skills, excellent communication and interpersonal skills, the ability to work independently and prioritize efficiently.
- Familiarity with AI systems and/or cybersecurity in medical devices is a plus.
What We Have to Offer
- Supportive and flexible work environment
- Remote-friendly culture
- Access to competitive benefits
- Mission-driven teammates who are working to tackle complex challenges to help improve the accessibility and quality of medical diagnosis
- Core behaviors that inspire day-to-day interactions
- Dedication to career growth and development of our team members through mentorship programs and defined growth paths
- Virtual social and wellness events
Who We Are
Digital Diagnostics Inc. is a pioneering AI diagnostics company on a mission to transform the quality, accessibility, equity, and affordability of global healthcare. We pursue our mission through the application of technology in the medical diagnosis and treatment process. The company, originally founded by Michael Abramoff, MD, PhD, a neuroscientist, practicing fellowship-trained retina specialist, and computer engineer, is led in partnership with co-founders, John Bertrand, and Seth Rainford. Digital Diagnostics’ first FDA De Novo cleared autonomous AI system, LumineticsCore™ (formerly IDx-DR), is already improving patient outcomes by detecting diabetic retinopathy (including macular edema) at the point-of-care.
Digital Diagnostics is paving the way for autonomous AI diagnosis to become a new standard of care, contributing to democratizing healthcare and closing care gaps. The company works closely with patient advocacy groups, federal regulators, and other quality of care and ethics-focused stakeholders to enable adoption of autonomous AI. For more information and the latest news follow: https://digitaldiagnostics.com/
Wat We Believe
At Digital Diagnostics, we’re doing “AI the right way” by building healthcare solutions that are safe, equitable, and accessible. We’re not only building a platform; we’re also building a community that emulates these values. We believe that inclusion and equity in healthcare start with a community of collaborators that celebrates human differences including race, ethnicity, gender, age, sexual orientation, human need, veteran status, political affiliation, and religion. We value what makes each person unique and create a place for everyone to thrive as we build towards shared goals. We’re committed to continuous learning and are striving to create a principled workplace while continuing to impact the world around us.
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This position can be located anywhere in the United States. We are not currently accepting applications for candidates located in countries outside of the U.S.Unfortunately, we are not able to sponsor an immigration case for employment at this time (for example, H-1B or other employment-based immigration cases).
No external agencies at this time, please.
