Bioinformatics Quality Engineer I

Abbott; United States; On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott is seeking a Bioinformatics Quality Engineer I in La Jolla to ensure the quality of medical device software for IVD, IUO and LDT products. You will design and execute verification/validation protocols for bioinformatics pipelines handling Next Generation Sequencing data in cancer diagnostics.

You will collaborate with software and bioinformatics teams to ensure requirements are met, and you will contribute to testing and documentation in a regulated environment.

Qualifications

• B.S. Degree in Bioinformatics, Computational Biology, Computer Science, or related field.
• 0–2+ years in software quality/test engineering or bioinformatics.
• Knowledge of SDLC and Agile/Scrum.
• Experience creating verification documentation: Verification Plans and Reports, Traceability Matrix, SOPs.
• Understanding of best practices for software development (Git, agile, code reviews, CI/CD).
• Experience with Quality Management System.

Responsibilities

• Develop and execute verification and validation protocols and generate test reports for medical device software and LDT products.
• Translate requirements into executable verification/validation protocols with full lifecycle traceability.
• Collaborate with bioinformatics scientists and operations to guide testing strategy and tooling.
• Test product functionality and confirm capabilities; ensure regulatory documentation readiness.
• Maintain alignment with the Quality Management System and communicate documentation needs across the team.

Skills

Software testing

Agile/Scrum

Quality documentation

Communication skills

Education

B.S. Degree in Bioinformatics

Tools

Git

CI/CD

Docker

Kubernetes

JAMA

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 Freedom2Save 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:

• 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 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 Qualifications

• 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is $81,500.00 – $141,300.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Product Development

DIVISION: ONCO Cancer Diagnostics

LOCATION: United States > La Jolla : Torrey Pines Science Park

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Yes, 5 % of the Time

MEDICAL SURVEILLANCE: No

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.