Abbott is hiring a Bioinformatics Quality Engineer I for its Cancer Diagnostics Division. The role ensures the quality and regulatory compliance of medical device and diagnostic software by testing, verifying, and validating bioinformatics pipelines, and collaborating with software, bioinformatics, regulatory, and quality teams.
Develop and execute verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products
Translate user and software requirements into executable software verification and validation protocols. This includes the full lifecycle focused on the creation of software requirements, testing, verification, and traceability
Work closely with bioinformatics scientists and operations to identify test inputs and provide technical guidance on the development of algorithmic test strategy, testing tools, and testing methodology
Test product functionality and/or confirm product capabilities
Work closely with Regulatory and Quality to provide the appropriate level of software documentation, compatible with regulatory requirements
Communicate documentation requirements to stakeholders across the organization
Contribute to test-driven development in the bioinformatics engineering team
Work on assignments individually and with project team members to meet department and project objectives
Work within project timeframes with successful outcomes on multiple projects and key responsibilities
Exercise excellent team working skills with ability to complete collaborative projects on time and within budget
Exercise excellent verbal and written communication skills with the ability to communicate complicated ideas and information effectively at all levels
Work towards challenging goals in a fast-moving environment where on-time delivery of results is a high priority
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
Qualification
Required
B.S. Degree in Bioinformatics, Computational Biology, Computer Science, Bioengineering or similar field as outlined in the essential duties
0-2+ years of experience spanning software quality/test engineering and/or bioinformatics
Knowledge of software development lifecycle (SDLC)
Familiarity with working in an Agile/Scrum environment
Proven capabilities in creating verification documentation: Verification Plan and Reports, Traceability Matrix, and Standard Operating Procedures
Understanding of best practices for software development (such as Git, agile, code reviews, CI/CD)
Experience working within a Quality Management System
Excellent communication skills (both written and oral) with the ability to communicate complicated ideas and information effectively at all levels
Preferred
Understanding of bioinformatics pipelines within Next Generation Sequencing and PCR applications
Programming Fluency in Python
Experience with automated software testing (unit, integration, system, end to end) preferably in the context of medical devices software such as bioinformatics analysis pipelines
Familiar with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc
Familiar working with cloud platforms (AWS Healthomics, Azure)
Experience within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software
Experience with medical device requirements such as Quality System Regulation (21 CFR part 820) ISO 14971 Medical Device Risk Management, ISO 13485, etc
Familiarity with bioinformatics analysis pipeline frameworks
Familiarity with software related Cybersecurity risk management such as FDA Cybersecurity guidance, IEC27000 series, IEC 15408, etc
Experience managing requirements in a validated Requirements Management tool such as JAMA
Benefits
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution.
Tuition reimbursement.
The Freedom 2 Save student debt program.
FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
Abbott is a healthcare company that produces diagnostic kits, medical devices, nutritional products, and branded generic medicines.
