Bioinformatics Quality Engineer I

Abbott (abbottcareers2 board); San Diego (CA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Career development

Medical coverage

Generous retirement plan

Tuition reimbursement

Educational benefits

Job summary

Abbott in La Jolla, CA is seeking a Bioinformatics Quality Engineer 1 to ensure the quality of medical device software for IVD, IUO, and LDT products. This role includes verification, validation, testing, and documentation across all development phases, with a focus on NGS data pipelines and cancer diagnostics.

Join a distributed team of scientists and software engineers, contributing to regulatory compliance and high-quality software solutions in a fast-paced environment.

Qualifications

• 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

Responsibilities

• Develop and execute verification and validation protocols and generate test reports for software in medical devices and LDT products.
• Translate user and software requirements into executable software verification and validation protocols.
• Collaborate with bioinformatics scientists and operations to identify test inputs and provide guidance on test strategies, tools, and methodology.
• Test product functionality and confirm product capabilities.
• Coordinate with Regulatory and Quality to provide appropriate software documentation aligned with regulatory requirements.
• Communicate documentation requirements to stakeholders across the organization.
• Contribute to test-driven development in the bioinformatics engineering team.
• Work independently and with project teams to meet objectives.
• Operate within project timeframes with successful outcomes on multiple projects.

Skills

Quality assurance

Software testing

Verification & Validation

Attention to detail

Education

Bachelor's degree in Bioinformatics, Computational Biology, Computer Science, Bioengineering or similar field

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:

• 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, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our La Jolla location in the Cancer Diagnostics Division.

The Bioinformatics Quality Engineer 1 is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification activities to ensure quality and compliance for products. The Bioinformatics Quality Engineer 1 will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. Depending on the area of focus, the position is responsible for ensuring the creation and execution of verification protocols.

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, testing, integration and attention to detail. It places high value on peer review, software testing and documentation. This position will join a geographically distributed team of highly motivated bioinformatics and software engineers at the forefront of cancer diagnostics and will be required to collaborate closely with scientists, IT and others creating these solutions.

Essential Duties

Include, but are not limited to, the following:

• VERIFICATION AND VALIDATION (V&V) 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.

Minimum Qualifications

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 soft