Job-ID32571065Reference26-01225 Remote 50% Remote Requirements: B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties. Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications. Familiarity with production software development lifecycle. Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD). Ability to effectively communicate software system designs. Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels. Demonstrated ability to perform the essential duties of the position with or without accommodation.
Preferred Qualifications:
Experience with programming languages, ideally Python. Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines. Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc. Familiar working with cloud platforms (AWS, GCP, Azure). Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software. Familiarity with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc. Work experience is strongly preferred. Familiarity with bioinformatics analysis pipeline frameworks. Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc. as well as software audits is a plus. Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc.
