Bioinformatics Pipeline Test Engineer
Role summary
The Bioinformatics Pipeline Test Engineer will support the verification and validation of software solutions for medical devices and LDT products. This role involves translating user and software requirements into test protocols, collaborating with scientists and operations to define testing strategies, and testing product functionality. The engineer will also contribute to design controls and software documentation compliant with regulatory requirements, including participating in risk assessments. Familiarity with bioinformatics pipelines in NGS and PCR, production software development lifecycles, and best practices like Git and Agile are essential. Preferred qualifications include experience with Python, automated testing, cloud platforms, and regulated industry compliance.
Bioinformatics Pipeline Test Engineer
San Diego CA
Contract
Essential Duties
- VERIFICATION AND VALIDATION
- 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.
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.
