Principal Systems Engineer

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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 Principal Systems Engineer provides technical leadership, direction, and expertise in the design and development of instruments, software, or automation used in clinical laboratories to perform diagnostic tests. The Principal Systems Engineer works with project leads and teams to ensure that user, customer, and business needs are correctly translated into system and component level architectures, then selects technologies and designs module and system functions to create design specifications that can be implemented in a robust and verifiable manner. This role may also be responsible for supervision or mentoring of engineers.

Essential Duties

Include, but are not limited to, the following:

• Create and determine hardware and software architectures and workflows at system and component levels.

• Define and detail component functions, interfaces, signal, data, and information flows.

• Actively engage with key stakeholders to comprehend the spectrum of available technology options and collaborate on their integration and application to products.

• Evaluate and select technologies needed to meet design goals.

• Communicate pros and cons of technology and design options and reasons for selection.

• Champion introduction, learning, and implementation of new technologies.

• Conduct creative analyses and high-level decision making.

• Communicate and document designs and lead design and technical reviews.

• Collaborate with cross-functional teams responsible for the design and development of clinical diagnostic products to meet product design goals while maintaining compliance with the quality system requirements.

• Lead system development decisions affecting product development issues.

• Lead the process to identify problems, investigate alternatives, and collaborate on the ideation and confirmation of potential solutions.

• Serve as the technical lead on preparing reports and analysis and interpretation of data and results as related to system/software/hardware development and improvement.

• Actively participate with research and technology efforts to ensure alignment with strategic priorities.

• Prepare reports and analysis of results related to product performance improvements.

• Report status of assigned projects through the preparation of detailed reports and documentation that summarize progress and performance results.

• Interpret results of experiments and trials and recommend alternative approaches.

• Create, review, and approve design history file documentation.

• Present information and updates at project or departmental meetings.

• Work within established project timeframes.

• Manage external vendors to meet part and assembly design specifications.

• Apply excellent attention to detail and meticulous record keeping.

• Apply excellent analytical, problem solving, organizational, and decision-making skills.

• Ability to work collaboratively with scientists, engineers, and software programmers.

• 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 nights and/or weekends, as needed.

• Provides technical leadership, guidance, training, and mentoring.

• 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.

• Ability and means to travel between Exact Sciences locations.

Minimum Qualifications

• Ph.D. in Engineering or field as outlined in the essential duties; or Master's Degree in Engineering or field as outlined in the essential duties and 4 years of experience in lieu of a Ph.D.; or Bachelor's Degree in Engineering or field as outlined in the essential duties and 8 years of experience in lieu of a Ph.D.

• 10+ years of experience working in a biotech/IVD/medical device related setting.

• Demonstrated ability to work in a senior role with a well-established IVD or medical device company.

• Demonstrated ability to work with CFR 21 part 820 and ISO 13485 compliance for software and instrumentation development.

• Demonstrated ability to contribute to the development of successful medical device products.

• Demonstrated ability to work with assembly, integration, troubleshooting, and testing custom equipment and instrumentation.

• Advanced knowledge of engineering software tools used in a specific engineering discipline.

• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• Authorization to work in the United States without sponsorship

Preferred Qualifications

• 20+ years of experience working in a biotech/IVD/medical device related setting.

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Salary Range:

$174,000.00 - $277,000.00

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, 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.

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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.