Foresight Diagnostics is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. The Associate Software Design Quality Engineer will provide quality and compliance support to ensure products are developed per FDA 21 CFR Part 820, ISO 13485:2016, ISO:14971, and other applicable regulations.
Requirements
- Introductory level experience in applying software quality practices to regulated medical device products or introductory experience applying software development life cycle methodologies in a regulated environment.
- Experience with root cause analysis techniques and risk management tools (i.e. FMEAs, system hazard analysis) is preferred.
Responsibilities
- Support the review of software deliverables for the Design History File for product launches for compliance with Quality System and Design Controls principles.
- Review software product requirements to ensure acceptance criteria and internal procedures have been met and are compliant with applicable regulations.
- Collaborate with the cross-functional teams to lead risk management activities and establish risk documentation per ISO 14971 for new product/service development projects to support regulatory submissions.
- Assist in the completion and maintenance of software risk files and other supporting deliverables.
- Support product development team with quality assessments of design changes, non-conformances, and impact on design history files and risk management files, as assigned by management.
- Assist with software opportunities for continuous improvement projects and Corrective & Preventative Action(s) (CAPA).
- Participate in FDA inspections, Notified Body audits, and other internal and external audits.
Other
- Minimum 1-3 years of experience in a diagnostic, medical device, or life sciences technology driven company.
- High attention to detail.
- Ability to work independently or as part of a cross-functional team in a fast-paced, changing environment.
- Growth mindset with curiosity, adaptability and willingness to learn.
- Ability to work independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
