Bioinformatics Pipeline Test Engineer (Fresher)
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Job Location:
San Diego, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Bioinformatics Pipeline Test Engineer (Fresher)
Job Location: San Diego CA (Onsite from Day 1 of Joining)
Job Duration: 6 Months
JD in brief:
For these candidates its imperative to have NGS pipeline experience or education. Working with Illumina sequencing data AWS healthomics Nextflo Type experience working on secondary analysis pipelines
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.
- Utilizing standardized procedures and practices work on assignments individually and with project team members to achieve department and project objectives and meet deadlines.
- Exercise excellent verbal and written communication skills with the ability to communicate basic technical information.
- Work towards challenging goals in a fast-moving environment.
- Uphold company mission and values through accountability innovation integrity quality and teamwork.
- Support and comply with the companys Quality Management System policies and procedures.
- Maintain regular and reliable attendance.
- Ability to act with an inclusion mindset and model these behaviors for the organization.
- Ability to work on a mobile device tablet or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability and means to travel 10% between local Exact Sciences locations.
- Ability to travel 5% of working time away from work location may include overnight/weekend/international travel.
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.
