Weekend Bioinformatics Analyst Jobs (NOW HIRING)

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Position Overview

The Senior 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

• Bachelor's Degree in Computer Science; or high school degree/general education diploma and 6 years of relevant experience in lieu of degree.
• 6+ years of experience working in quality assurance of enterprise applications.
• 4+ years of experience in web-based enterprise application testing.
• 4+ years of experience working in an Agile/Scrum-like environment.
• 4+ years of experience using one or more tools, such as, Jenkins, GitLab, Postman, SOAPUI, JMeter, Selenium, or TestNG.
• Demonstrated ability to conduct system end-to-end and integration test strategies to identify issues attributed to inconsistencies between business processes or the planned interactions of components.
• Demonstrated ability to create audit materials to support compliance needs for SOX, BSI, SDLC, and/or ISO-13485, and design control for regulatory products.
• Demonstrated proficiency with programming or scripting languages, such as Ruby, Python, Perl, Groovy, Java, or JavaScript and database testing experience.
• Proficient in the Agile/Scrum software development lifecycle.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

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.

Salary Range:

$131,700 - $182,300

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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