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At Exact Sciences, were 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 youre working to help others.

Position Overview

The Staff Engineer I, Systems Hardware is responsible for planning, executing, and managing the mechanical hardware design, development and testing of mechanical components and electro-mechanical assemblies used in instruments and equipment to be used for in vitro diagnostic tests designed by Exact Sciences. This engineer uses a technical background in mechanical engineering, combined with an understanding of system design and design control principles, to analyze user needs, requirements and design details, in order to create and implement mechanical sub-assemblies that provide structure and integrate with motors and circuits that control motion and sensors in instrument systems.

The Staff Engineer I, Systems Hardware exercises advanced judgment within broadly defined practices and procedures to determine appropriate action or in selecting methods, techniques and evaluation criteria for obtaining solutions. A Staff Engineer I supports a collaborative environment that promotes positive teamwork where all members are working for the good of Exact Sciences.

Essential Duties

Include, but are not limited to, the following:

• Design hardware/mechanical architecture within system architecture, decompose into modules and units.
• Create detailed mechanical designs at unit, interface, module, and system levels.
• Estimate work required to develop and implement mechanical hardware designs.
• Design supports and interfaces for sensors and motors.
• Use mechanical CAD software to model and diagram complex mechanical hardware.
• Select materials and components to implement mechanical hardware designs.
• Create and manage schedules for implementation of hardware designs.
• Design, build, and troubleshoot prototypes and test fixtures.
• Determine and plan mechanical testing strategies at unit, module, and integrated system levels.
• Document mechanical designs and tests, communicate test results.
• Track hardware development progress to plans.
• Select optimal fabrication methods for custom parts and assemblies.
• Transfer component designs to manufacturers.
• Manage external vendors to meet part/assembly design specifications.
• Collect and analyze user needs for completeness and translate into testable design requirements.
• Create and critically evaluate design concepts for function, reliability, and manufacturability.
• Contribute to design of system architectures.
• Lead or participate in risk and failure mode and effect assessments.
• Determine system, module, and unit design specifications.
• Translate product requirements and quality system requirements into hardware specifications.
• Participate in technical design decisions, identify potential problems, investigate alternate solutions and recommend best courses of action.
• Evaluate and troubleshoot prototypes and test fixtures.
• Troubleshoot system issues and failures, determine root cause of failures and recommend corrective actions.
• Create and review design control documentation.
• Effectively record, reproduce, and communicate software and hardware issues (bugs) and contribute to their resolution.
• Report status of assigned projects and tasks: work complete, work to do, velocity.
• Contribute ideas for new products and product improvements.
• Provide expertise and leadership to teams and foster a culture of teamwork.
• Gather input from collaborators, partners, team members and suppliers to define goals and establish a path to meeting those goals.
• Collaborate cross-functionally with the Clinical Laboratory, Pipeline, Clinical Affairs, Regulatory, Quality Control, Operations and other stakeholders to support and improve processes and procedures that drive quality and productivity.
• Represent R&D Systems Development in cross-functional initiatives, as assigned, and act on behalf of the department as appropriate.
• Work on problems which are extremely complex in scope in which analysis of data requires an evaluation of intangible variables.
• Act as technical leader for one or more projects that are complex in scope.
• Exercise discretion and independent judgement within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining and interpreting results, analyzing data, and presenting findings in a professional and knowledgeable manner.
• Partner effectively with colleagues across multiple functions and at all levels of the enterprise.
• Ability to effectively contribute toward team goals.
• Ability to effectively work on many complex and varied projects at one time, while navigating and adapting to ambiguous and changing plans and circumstances.
• Incorporate advanced inputs from cross functional stakeholders into product designs.
• Utilize advanced written and oral communication to inform and influence stakeholders, resolve conflicts, build consensus, and drive focus.
• Utilize advanced technical writing skills to document designs, record results, and build design history files.
• Break down advanced goals into sequences of less complex goals.
• Work on many complex and varied projects at one time, while navigating and adapting to ambiguous and changing plans and circumstances.
• Demonstrate advanced investigative, analytical, deductive, and problem-solving skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the companys 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.
• 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 work equipment designed for standing interaction for up to 80% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to use various types of hand tools and laboratory equipment; including, but not limited to, wrenches, screwdrivers, pliers, cutters, screw cap containers, and pipettes for extended periods of time.
• May perform repetitious actions using hand or power tools.
• Constant walking or motion to coordinate work and interact with co-workers and equipment.
• May be required to work in presence of energy, electrical, kinetic (moving parts), extreme hot or cold temperature hazards with provided training and protective equipment.
• May be required to work with chemical or biological hazards with provided training and protective equipment.
• Ability and means to travel 80% of annual working time between base city locations.
• Ability to travel 10% of annual working time away from base city work locations, which may include overnight/weekend travel.

Minimum Qualifications

• Masters degree in mechanical engineering or field as outlined in the essential duties; or bachelors degree in mechanical engineering or field as outlined in the essential duties, with 2 years of relevant experience in lieu of a masters degree.
• 9+ years of experience in hardware development and testing.
• 5+ years of experience in medical device/IVD, biotech, life science or automation industry.
• Proficient with mechanical CAD, design for manufacturability, materials selection, setting design and manufacturing tolerances, stress and load analysis including finite element analysis.
• Demonstrated knowledge of hardware debugging and testing methods.
• Proficient computer skills to include internet navigation and email usage.
• Proficient in Microsoft Office programs, such as: Excel, OneNote, Outlook, Power Point, Teams, Visio and Word.
• 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

• Advanced degree in mechanical engineering, or related field.
• 9+ years of experience in medical device/IVD, biotech, life science or pharmaceutical industry.
• Knowledge of clinical laboratory instrumentation and procedures.
• Previous success in bringing diagnostic products to market under an IVDR or FDA-regulated environment.
• Proficient with Solidworks modeling and PDM vault software.

Salary Range:

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. Well 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 companys 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.