s Also Welcome JD in brief: For these candidates, it s 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 company s 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, Google Cloud Platform, 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.
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