Bioinformatics Pipeline Test Engineer
About The Position
This role focuses on the verification and validation of software solutions used in medical devices and LDT products, with a strong emphasis on Next Generation Sequencing (NGS) pipelines. The engineer will translate user and software requirements into test protocols, collaborate with bioinformatics scientists on test strategies, and test product functionality. Additionally, the role involves contributing to design controls and software documentation for the medical device software lifecycle, adhering to regulatory requirements and best practices for LDT software. The position requires participation in risk assessments, creation of compliant software documentation, and working both individually and collaboratively to meet project objectives in a fast-paced environment. Upholding company values, supporting the Quality Management System, and maintaining regular attendance are essential. The role involves significant computer use and requires some travel.
Requirements
- B.S. Degree in Computational Biology, Computer Science, or a related field.
- 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.
Responsibilities
- 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.
- 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.
- Act with an inclusion mindset and model these behaviors for the organization.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
