Engineer II, Systems Software

Exact Sciences • Madison, WI

2d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

Responsibilities

• 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

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level