Bioinformatics Pipeline Junior Test Engineer

Summary

Katalyst CRO is a company focused on bioinformatics and software development for medical devices. They are seeking a Bioinformatics Pipeline Junior Test Engineer to assist in the development and testing of bioinformatics pipelines within Next Generation Sequencing and PCR applications.

Skills

• 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
• 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

Qualifications

Must Haves

• 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

Nice to Haves

• 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