Bioinformatics Quality Engineer I

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Position Overview

The Bioinformatics Quality Engineer I will utilize existing procedures and standard practices to help the team ensure the quality of the medical device software for IVD, IUO and LDT products. With guidance from senior team members, this role will aid in the verification and validation processes to ensure quality and compliance, and in the development and maintenance of software design control documentation for the products. The Bioinformatics Quality Engineer I will be involved in software testing, verification, and validation of the bioinformatics pipelines in all phases of bioinformatics software and medical device system life cycle. Depending on the area of focus, the position will support the creation, update and timely delivery of software design control documents or the development and execution of verification and validation protocols and reporting.

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.

With a science and/or engineering background, this role will focus on quality and attention to detail and will aid in 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.

This position is onsite in San Diego.

Essential Duties

Include, but are not limited to, the following:

• VERIFICATION AND VALIDATION
  • With direction and guidance from the team lead, help with verification and validation protocols and generate test reports for multiple software solutions used in medical devices and LDT products.
  • Aid in translation of user and software requirements into executable software verification and validation protocols focusing on various aspects of the software lifecycle.
  • Collaborate with bioinformatics scientists and operations to identify test inputs and understand the development of algorithmic test strategy, testing tools, and testing methodology.
  • Test product functionality and/or confirm product capabilities.
• DESIGN CONTROLS
  • With direction and guidance from the team lead, help with design controls and appropriate software documentation (e.g. software requirements and/or specifications, architecture documents, software design details doc) for medical device software lifecycle.
  • Learn and apply best practices for LDT software and create and manage all applicable documentation.
  • Participate in risk assessments for software products, including identification of potential risk mitigations and traceability to software requirements.
  • Help with the creation of software documentation, compatible with regulatory requirements.
• Utilizing standardized procedures and practices, work on assignments individually and with project team members to achieve department and project objectives and meet deadlines.

• Exercise excellent verbal and written communication skills with the ability to communicate basic technical information.
• Work towards challenging goals in a fast-moving environment.
• 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.

• Familiarity with the development of bioinformatics pipelines within Next Generation Sequencing and PCR applications.
• Familiarity with production software development lifecycle.
• Familiarity with best practices for software development (such as Git, agile, code reviews, CI/CD).

• Ability to effectively communicate software system designs.
• 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

• Experience with programming languages, ideally Python.
• Familiar with automated software testing, preferably in the context of medical devices software such as bioinformatics analysis pipelines.
• Familiarity with container orchestration concepts and systems, e.g. Docker, Kubernetes, etc.
• Familiar working with cloud platforms (AWS, GCP, Azure).
• Familiarity within an FDA-Regulated, Medical Device, Pharmaceutical, Biotech, or other regulated industry, developing CFR 21 Part 11 and IEC 62304 compliant software.
• Familiarity 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. as well as software audits is a plus.
• Familiar with managing requirements in a validated RM tool such as JAMA, DOORS, etc.

Salary Range:

$80,000 - $120,000

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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