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Position Overview

The Senior Bioinformatics Quality Engineer I is responsible for ensuring the quality of the medical device software for IVD, IUO and LDT products. This entails executing verification and validation processes to ensure quality and compliance, as well as development and maintenance of software design controls for the products. The Sr Bioinformatics Quality Engineer I will be involved in testing, verification, and validation of the bioinformatics pipelines in all phases of system development. This position is responsible for ensuring the creation, update and timely delivery of design controls and aiding in the development of verification and validation 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. This position will be responsible for supporting software queries in audits.

With extensive science and/or engineering background, this role requires a strong focus on quality and attention to detail, and places high value on 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 may be remote.

Essential Duties

Include, but are not limited to, the following:

• Be accountable for design controls for medical device software and best practices for LDT software and create and manage all applicable documentation.
• Participate in creation and management of software requirements.
• Participate in design feasibility assessments of medical device software.
• Participate in risk assessments and hazard analysis 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.
• Aid testers in the translation of user and software requirements into executable software verification and validation protocols.
• 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.
• Familiar with software testing in the context of medical devices software such as bioinformatics analysis pipelines.
• 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:

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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