Quality Engineer Medical Devices
We are building the next generation of AI based software tools for cancer imaging and treatment.
Limbus AI is a software company that develops machine learning based products designed to improve efficiency in cancer diagnosis, treatment, and follow up.
Our main product utilizes machine learning models to perform accurate and fast segmentation of organs at risk - a critical component of radiotherapy treatment planning.
We are based in Canada but have a decentralized work environment with individuals located across Canada and in the United States. We offer a respectful, friendly, open, team oriented working environment with flexible time management, and competitive salaries.
Join our team and help us build state of the art machine learning driven medical software.
Job Description
In this role, you will be responsible for supporting product development by ensuring compliance with design control and quality system regulations and standards, particularly ISO 13485, IEC 62304/82304, and other common software medical device standards. You will manage design verification, participate in cross-functional teams, evaluate suppliers, maintain quality system records, and lead risk analysis per ISO 14971.
Responsibilities
- Support product development team in the area of design control to ensure compliance to the Quality System Regulation (ISO 13485, others) design control requirements.
- Participate in developing and improving Standard Operating Procedures and/or Work Instruction as part of the Quality Management System procedures.
- Support the software development team to ensure compliance to IEC 62304/82304 and other relevant standards.
- Ensure adherence to medical device cybersecurity requirements and best practices to protect sensitive data and maintain device integrity.
- Responsible for managing Design Verification testing including writing test protocols, execution of verification testing and non-human (bench) design validation testing.
- Participate in cross-functional meetings with internal and external parties as required.
- Participate in new supplier evaluation, work with suppliers to ensure appropriate quality deliverables and activities are implemented as needed.
- Support management and tracking of quality system records (e.g. DHF audit, Corrective and Preventive Actions, and Effectiveness Checks) for adherence to organizational or departmental targets.
- Maintain and package product technical documentation and design history for medical device regulatory submissions and registrations.
- Lead the development of Risk Analysis per ISO 14971 along with development team, support other activities such as Design Verification and Validation Testing.
- Implement appropriate Quality Engineering practices including statistical analysis, root cause analysis, and reliability engineering.
- Other tasks as assigned by management.
Knowledge and Skills
- Strong problem solving skills
- Demonstrated ability to work collaboratively on cross-functional teams in a fast moving environment
- High level of initiative with ability to self-manage
- Strong interpersonal skills with ability to work both independently and as part of a team
- Excellent written and verbal communication skills
Qualifications
- Bachelor's degree in Computer Science, Engineering, Physics, or a related field
- Demonstrates working knowledge of current ISO 13485 standard and QSR.
- Working knowledge or familiarity with IEC 62304/82304, IEC 62366, and ISO 14971.
Extra Credit
- Experience with web development
- Experience in or knowledge of radiation therapy
- Experience in software architecture design and development
Application Process
Qualified candidates should submit a resume and cover letter. The cover letter should include information on your availability, and how your previous experience relates to the job requirements: specific examples are of interest. All your information will be kept confidential.
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