Engineer II, Systems Verification

Exact Sciences • Madison, WI

1d • Onsite

About The Position

The Engineer II, Systems Verification works with the systems development team to ensure that custom in vitro diagnostic systems meet design and customer requirements. The Engineer II, Systems Verification uses a technical background in software development and engineering, combined with an understanding of the system design to analyze user needs, requirements, and specifications to lead verification test projects, create testing strategies and plans for verification and validation of the system designs.

Requirements

• Bachelor’s Degree in Engineering, Computer Science, or related field as outlined in the essential duties; or High School Degree/General Education Diploma and 4 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
• 3+ years of relevant experience as outlined in the essential duties.
• Proficient in Microsoft Office.
• 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 devices or related area.
• Experience in an FDA-regulated environment, ideally in medical device development.
• Track record of contributions to successful software launches, from initial concept to customer release.

Responsibilities

• Participate in all aspects of the software and product development lifecycles.
• Analyze user needs, software and hardware specifications, product requirements, and quality system requirements for complex projects.
• Review and create design control documents with team input.
• Design testing strategies and detailed test plans for functional verification of complex systems at module, unit, and system levels to ensure that product requirements, quality system requirements, regulatory requirements, and design specifications have been met.
• Apply risk-based testing approaches based on risk assessments and white box understanding of internal system architecture and function.
• Maintain and improve existing test assets.
• Lead the investigation, reproduction, recording, and communication of software and hardware issues and defects.
• Lead creation of user and trouble-shooting manuals for service personnel.
• Plan, schedule, and execute test plans comprised of multiple test suites and record results and findings for systems of complex scope.
• Create and apply software-driven and automated testing tools.
• Troubleshoot system issues and failures.
• Work collaboratively in cross-functional teams.
• Train and mentor novice personnel.
• Apply excellent written and verbal communication skills.
• 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.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to operate laboratory instruments and equipment, up to 8 hours per day.
• 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 to comply with any applicable personal protective equipment requirements.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

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: Mid Level
• Education Level: Associate degree