Help us change lives

At Exact Sciences, we're helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Associate Director, Bioinformatics Quality Engineering is responsible for leading the development and maintenance of software design controls associated with the development of medical device software for IVD, IUO and LDT products, and for successfully taking these products through verification and validation processes to ensure quality and compliance. This role will provide leadership to a team of Bioinformatics Quality and Systems Engineers by working to define clear and realistic goals and developing a general management view of the project. The position will participate in timeline development and in planning for new assignments/projects.

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 the purpose of cancer diagnostics. As a subject matter expert, this position will guide development teams through software requirements for new products and manage changes to existing software to ensure compliance for IVD, IUO and LDT products. This position will be responsible for supporting software queries in audits. Working in a team setting, this role will be involved in investigating new technologies to improve and streamline the software development, testing and documentation processes.

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:

* Lead the verification and validation efforts across multiple software solutions used in medical devices and LDT products.

* Oversee the translation of 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.

* Be accountable for and own the processes for adherence to applicable regulations such design controls for medical device software and best practices for LDT software.

* Assess design feasibility and test product functionality and/or confirm product capabilities.

* Contribute towards the development of timeline and plan for new assignments/study/projects.

* Mentor team members with a focus on software quality processes for regulated medical devices.

* Communicate documentation requirements to stakeholders across the organization.

* Lead and 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.

* Institutionalize development best practices and evangelize test-driven development in the bioinformatics engineering team.

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

* Act as a leader and subject matter expert for one or more projects and in core team and/or cross-functional meetings.

* 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.

* Effectively manage, support, and guide your team, including, but not limited to delegating tasks and responsibilities, assess employee performance and provide helpful feedback and training opportunities.

* Consistent demonstration of exceptional leadership qualities, including, but not limited to the ability to attract and retain the best team, foster a culture of high performance, lead with integrity, humility, accountability, and courage, and set a clear vision to energize teams towards the future.

* 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.

* Demonstrated ability working 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.

* 8 years of experience spanning software quality engineering and medical device systems engineering.

* 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.

* Polyglot background with fluency in Python.

* Advanced level knowledge of production software development lifecycle.

* Advanced knowledge of and experience with automated software testing (unit, integration, system)

* Ability to effectively communicate software system designs.

* Expertise in best practices for software development (such as Git, agile, code reviews, CI/CD).

* Experience of establishing or 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.

* 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 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.

#LI-AN1

Salary Range:

$167,000.00 - $267,000.00

The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to receive company stock upon hire as well as annually.

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, email hr@exactsciences.com. We'll work with you to meet your accessibility needs.

Not ready to apply? Join our talent community and stay up to date on what's new at Exact Sciences.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.