Sr. Bioinformatics Quality Engineer

Abbott • La Jolla, CA

5d • Onsite

About The Position

This position works out of our La Jolla, CA location in the Cancer Diagnostics Division. The Senior Bioinformatics Quality Engineer is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification and validation processes to ensure quality of products. The Sr Bioinformatics Quality Engineer will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. The position is responsible for ensuring the creation and execution of verification plans, protocols, and reports. Working in a team setting, this role will contribute to the implementation of new software solutions that process and interpret Next Generation Sequencing (NGS) data for cancer diagnostics. This role will work with software and bioinformatics teams to ensure development satisfies requirements, also guiding software changes to ensure adequate testing and compliance for IVD, IUO and LDT products. With an extensive science and/or engineering background, this role requires a strong focus on quality and attention to detail, and places high value on peer review, software testing and documentation. This position will join a geographically distributed team of highly motivated bioinformatics engineers at the forefront of cancer diagnostics and will be required to collaborate closely with scientists, IT and others creating these solutions.

Requirements

• B.S. Degree in Bioinformatics, Computational Biology, Computer Science, Bioengineering, or similar field as outlined in the essential duties.
• 5+ years of experience spanning software quality/test engineering and/or bioinformatics.
• Knowledge of production software development lifecycle.
• Familiarity with working in an SDLC/Agile/Scrum environment.
• Proven capabilities in creating verification and validation 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.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.

Nice To Haves

• 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. 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.
• Experience managing requirements in a validated Requirements Management tool such as JAMA

Responsibilities

• Develop and execute verification plans, protocols and generate test reports for multiple software solutions used in medical devices and LDT/IVD 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.
• Mentor team members with a focus on software quality processes for regulated medical devices.
• Communicate documentation requirements to stakeholders across the organization.
• Institutionalize development best practices and evangelize 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.
• 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 Abbott Cancer Diagnostics locations.

Benefits

• 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, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior