Engineer II, Systems Software

Help us change livesAt 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 OverviewThe Engineer II, Systems Software is responsible for designing, developing, and testing medical device software that controls automated systems and laboratory equipment. This position plays a critical role in helping bring products to life by working with scientists to automate wet-lab processes and create medical device software that operates in high-throughput clinical lab settings and directly impacting patients’ lives. Responsibilities include developing new tests or modifying existing tests, working across the software development lifecycle supporting FDA regulations and design controls, and developing internal software tools used in R&D, service, or quality control. This role requires employing engineering concepts across many disciplines (software, mechanical, electrical, biomedical, etc.) to solve problems within complex systems.Essential Dutiesinclude but are not limited to the following:Write software that interfaces with mechanical and electrical systems, primarily liquid handling instrumentsWrite software that interfaces with larger software systems for data management and sample trackingDesign and develop robust automation solutions for high-throughput use, in FDA medical device regulated environmentsWork with cross-functional teams to translate manual wet-lab processes into automation solutions for scalable and high throughput useDesign experiments studying impact of software controls on mechanical systems and document the results under good documentation practices (GDP)Write experimental protocols and document results in formal test plans and reportsParticipate in all aspects of the software development lifecycleWrite technical documents under formal design controls (FDA 21 CFR 820.30) for medical devicesTranslate product requirements and quality system requirements into software specificationsReview and create software design control documents with team inputContribute to the architecture of software driven systemsDocument software designs and applications using generally accepted notation such as UMLMaintain and improve the performance of existing softwareReview and debug complex softwareCode software applications with associated unit testsDevelop and execute test plans at module/unit and system levels. Develop test plans to ensure that product requirements, quality system requirements, regulatory requirements, and design specifications have been metGenerate and contribute content to include in software user’s and service manualsCreate internal software tools to enhance data analysis and data management productivityTroubleshoot issues across electrical, mechanical, and software systemsMentor junior engineers and interns to develop their skills. Facilitate training of junior engineers on current software and software development practicesSupport and comply with the company’s Quality Management System policies and proceduresApply professional written and verbal communication skillsWork collaboratively in teamsOther duties as assignedMinimum Qualifications:Bachelor’s degree in engineering, computer science or related field3+ year of relevant industry experienceAuthorization to work in the United States without sponsorshipDemonstrated ability to perform the Essential Duties of the position with or without accommodationPreferred Qualifications:5+ years of experience following quality system/design control in medical device or related area, and a track record of contributions to successful software launches, from initial concept to customer releaseKnowledge of the software lifecycle for a medical deviceExperience in medical device developmentExperience with liquid handling instruments, particularly Hamilton ML_STAR instrumentsStrong technical writing skillsNew grads welcome to apply.Salary Range:$84,000.00 - $138,000.00The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.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.Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences.We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.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.