Sr. Bioinformatics Quality/Test Engineer

The Senior Bioinformatics Quality/Test Engineer I is responsible for leading the testing efforts for all software components of an end-to-end clinical assay. Responsibilities include overseeing the overall test strategy, planning, and release of all software components. This is a role within the scrum team, collaborating closely with Development and Product Owner leads to ensure a robust scrum and release process.

This position is onsite at our San Diego location.

Essential Duties

Include, but are not limited to, the following:

• VERIFICATION AND VALIDATION

  • 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, hazard analysis, testing and validation. 

  • 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. 

• DESIGN CONTROLS

  • Be accountable for design controls for medical device software and best practices for LDT software and create and manage all applicable documentation.

  • Participate in design feasibility assessments of medical device software.

  • Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements.

  • 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.  

• Take part in audits, representing software activities and answering queries. 

• Work on problems of extremely complex scope in which analysis of data requires an evaluation of intangible variables. 

• Exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining solutions.

• 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 Exact Sciences locations. 

• Ability to travel 5% of working time away from work location, may include overnight/weekend/international travel. 

Minimum Qualifications

• B.S. Degree in Computational Biology, Computer Science, or field as outlined in the essential duties.

• 4+ years of experience spanning software quality engineering and medical device systems engineering and bioinformatics. 

• Demonstrated deep understanding of and competence in the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.

• Knowledge of production software development lifecycle.

• Proven capabilities in creating verification and validation documentation, including GxP Assessments, Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating Procedures.

• Understanding of best practices for software development (such as Git, agile, code reviews, CI/CD). 

• Ability to effectively communicate software system designs. 

• 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.

Preferred Qualifications

• Master’s or Ph.D. degree is preferred. 

• Polyglot background in programming languages with fluency in Python. 

• Experience with automated software testing (unit, integration, system) 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, GCP, 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 with PAI, ISO and MDSAP audits is a plus.  

• Experience managing requirements in a validated RM tool such as JAMA, DOORS, etc.