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Position Overview
The 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 Duties
include but are not limited to the following:
Write software that interfaces with mechanical and electrical systems, primarily liquid handling instruments
Write software that interfaces with larger software systems for data management and sample tracking
Design and develop robust automation solutions for high-throughput use, in FDA medical device regulated environments
Work with cross-functional teams to translate manual wet-lab processes into automation solutions for scalable and high throughput use
Design 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 reports
Participate in all aspects of the software development lifecycle
Write technical documents under formal design controls (FDA 21 CFR 820.30) for medical devices
Translate product requirements and quality system requirements into software specifications
Review and create software design control documents with team input
Contribute to the architecture of software driven systems
Document software designs and applications using generally accepted notation such as UML
Maintain and improve the performance of existing software
Review and debug complex software
Code software applications with associated unit tests
Develop 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 met
Generate and contribute content to include in software user’s and service manuals
Create internal software tools to enhance data analysis and data management productivity
Troubleshoot issues across electrical, mechanical, and software systems
Mentor junior engineers and interns to develop their skills. Facilitate training of junior engineers on current software and software development practices
Support and comply with the company’s Quality Management System policies and procedures
Apply professional written and verbal communication skills
Work collaboratively in teams
Other duties as assigned
Minimum Qualifications:
Bachelor’s degree in engineering, computer science or related field
3+ year of relevant industry experience
Authorization to work in the United States without sponsorship
Demonstrated ability to perform the Essential Duties of the position with or without accommodation
Preferred 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 release
Knowledge of the software lifecycle for a medical device
Experience in medical device development
Experience with liquid handling instruments, particularly Hamilton ML_STAR instruments
Strong technical writing skills
New grads welcome to apply.
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Salary Range:
$84,000.00 - $138,000.00
The 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.
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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.
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