Bioinformatics Pipeline Test Engineer

Essential Duties

• With direction and guidance from the team lead, help with verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products.
• Aid in translation of user and software requirements into executable software verification and validation protocols focusing on various aspects of the software lifecycle.
• Collaborate with bioinformatics scientists and operations to identify test inputs and understand the development of algorithmic test strategy, testing tools, and testing methodology.
• Test product functionality and/or confirm product capabilities.

Design Controls

• With direction and guidance from the team lead, help with design controls and appropriate software documentation (e.g. software requirements and/or specifications, architecture documents, software design details doc) for medical device software lifecycle.
• Learn and apply best practices for LDT software and create and manage all applicable documentation.
• Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements.
• Help with the creation of software documentation, compatible with regulatory requirements.

Qualifications

• Minimum Qualifications:
• 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.

About the Role

Vytwo Technologies is a global leader in enterprise application integration, delivering end-to-end IT consulting and business services for mid to large-scale organizations.

We offer a comprehensive suite of solutions including business and technology consulting, Cloud, e-business and digital transformation services, system integration, custom application development, re-engineering, and long-term application support.

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