Exact Sciences

Senior Systems Hardware Engineer

1 week agoMadison, WI

Summary of Major Responsibilities

The Senior Systems Hardware Engineer works with the Systems Development team to design, develop, and test customized instruments, automation equipment, and consumables to be used in the laboratory environment or field. This position will lead the hardware design architecture and development, test methodology and strategy, design trade-offs, cost-benefit analyses, and quality decisions. This position will be responsible for project management activities; including scheduling, documentation, parts procurement, and BOM (Bill of Material) management.

Essential Duties and Responsibilities

  • Determine system design specifications and create and evaluate design concepts.
  • Design, build, and troubleshoot prototypes and test fixtures.
  • Develop and write test plans to ensure that product requirements, quality system requirements, regulatory requirements, and design specifications have been met.
  • Execute testing to measure system performance, analyze data, and prepare formal reports to document results.
  • Review and author design control documents.
  • Contribute to system design history files.
  • Manage external vendors to meet part/assembly design specifications.
  • Lead the designs of new products and improve and maintain existing products.
  • Provide technical leadership to team members; apply thorough engineering design and development skills and mentor less-experienced engineers.
  • Exhibit excellent communication skills; ability to work effectively with cross-functional team members.
  • Strong written documentation, verbal communication, and presentation skills.
  • Self-motivated; strong analytical and problem-solving skills.
  • Ability to work with or support systems technicians for specific task-related activities.
  • Ability to work with other team members to keep lab areas clean and organized.
  • 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 lift up to 75 pounds on an occasional basis.
  • Ability to work seated for approximately 75% of a typical working day. Ability to work standing for approximately 25% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% 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 assemble/disassemble fasteners on instruments; including screws, bolts, etc.
  • Ability and means to travel between Madison locations.
  • Ability to travel 10% of working time away from work location, may include overnight/weekend travel.


Minimum Qualifications

  • Bachelor’s degree in mechanical engineering, biomechanical engineering, or related field.
  • 7+ years of progressively responsible, relevant work experience in a similar role as outlined in the essential duties.
  • 3+ years of experience using Solidworks with the demonstrated ability to use Solidworks for the design modeling and drawing of complex mechanical and electromechanical parts, assemblies, and instruments.
  • 3+ years of experience with design, assembly, and testing of laboratory robotics, automation equipment, and mechanical or electromechanical systems under Quality Systems Regulation (QSR) design controls.
  • 3+ years of experience managing external vendors and/or consultants.
  • 3+ years of experience with multiple types of materials and manufacturing processes.
  • 3+ years of experience designing tight-tolerance, high-precision parts, and assemblies.
  • Demonstrated record of contributions to successful product/instrument launches, from initial concept to design transfer or production implementation.
  • Proven ability to successfully demonstrate DFMEA and DFA techniques.
  • Demonstrated ability to perform detailed tolerance (stack-up) analyses and evaluate design factors critical to form, fit, and function with high attention to design details.
  • Demonstrated ability to evaluate and select optimal fabrication and manufacturing methods based on factors such as cost, lead time, tooling, etc.
  • Demonstrated detailed record keeping under Quality Systems Regulation (QSR) or similar environment.
  • Comprehensive knowledge of ASME GD&T (Y14.5), statistic methodology, and six sigma techniques, including Design of Experiments (DOE).
  • Proficient with Microsoft Office; including Project, Word, Excel, and PowerPoint.
  • 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

  • 3+ years of experience with FEA (Finite Element Analysis).
  • 2+ years of experience with Solidworks Simulation.
  • 1+ years of experience with Solidworks PDM Vault.

EEO Disclosure

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. Applicable portions of the Company’s affirmative action program are available to any applicant or employee for inspection upon request.

Job ID: 59567455