• Sustaining Engineer, Software

    Job Locations US-WI-Madison
    Req No.
    Manufacturing Operations, Facilities & Security
    Regular Full-Time
  • Summary of Major Responsibilities

    The Sustaining Engineer, Software, is a member of the sustaining engineering team responsible for providing continuing engineering and technical support following release of products to manufacturing. Sustaining Engineering is the owner of process and product post release with expectations to deliver quality and cost improvements for the customer and the company while always complying with safety and regulatory requirements. This role supports the designs and tests software, electrical, or mechanical sub systems used for automation of in vitro diagnostic tests or their manufacture. 

    Essential Duties and Responsibilities

    • Troubleshoots and resolves production system and customer software issues, against all application tiers.
    • Collaborates with Technical Services and R&D to evaluate incoming custom development requests from customers, propose technical solutions that will satisfy enhancement requests, and complete development for these projects as assigned.
    • Owns assigned projects and drives them to completion in a timely manner.
    • Ensures that projects meet technical requirements and comply with development and technology standards.
    • Collaborates with QA to ensure that software deliverables have been well tested.
    • Learns new technologies, as needed.
    • Develops and implement software of embedded devices and systems for automation system or customer request tools.
    • Isolates and root causes product issues in complex customer environments.
    • Works with cross functional members to Identify and drive to resolution product fixes and process improvements to improve the customer experience.
    • Contributes to additional tasks and responsibilities that will contribute towards team, department and company goals.
    • Manages compliance activities such as CE marking, ROHS, CSA, and compliance documentation for medical device product lines.
    • Analyzes root cause analysis for production failures specific on software interface with hardware design and development.
    • Responds to requests for support from Exact Sciences Laboratories, Technical Services, and Manufacturing Operations groups needing technical analysis.
    • Provides oversight of key production tools. Drives process and facilities continuous improvement activities.
    • Partners with systems engineers, manufacturing operations, quality, supply chain, project management and product management.
    • Practices design for manufacturability and assembly (DMFA) and lean manufacturing principles.
    • Supports and complies with the company’s Quality Management System policies and procedures.
    • Regular and reliable attendance.
    • Ability to work normal schedule of Monday through Friday during normal business hours.
    • Excellent oral and written communication skills.
    • Strong attention to detail and record keeping skills required in a GMP environment.
    • Ability to lift up to 45 pounds for approximately 5% of a typical working day.
    • Ability to work 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 approximately 15% of working time.


    Minimum Qualifications

    • Bachelor’s degree in computer sciences or a related field or high school degree/general education diploma and 4 years of relevant experience in lieu of degree.
    • 3+ years of manufacturing and software programming experience in a medical device or related field.
    • 3+ years of engineering tools/processes experience – PPAP, DVP&R, DFMEA, PFMEA, DFMA, ECO, ERP systems, BOM structures.
    • 3+ years of experience with process and industrial automation equipment and requirements.
    • Authorization to work in the United States without sponsorship.
    • Professional experience in writing, reading, and interpreting the documentation of engineering designs and production processes to produce quality deliverables.
    • Experience with safety and health (OSHA), FDA and ISO 13485 quality system requirements.
    • Demonstrated ability to work with MS Word, Excel, PowerPoint, Project and Outlook.
    • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

    Preferred Qualifications

    • 3+ years of combined experience with coding in C+, C++, and Hamilton Robotics.
    • Understanding of instrumentation products, mechanics and electronics.
    • Regulatory agency experience/knowledge (UL, CSA, CE, ROHS).
    • Experience in developing company engineering policies and procedures.
    • Understanding/practice Design for Manufacturability & Assembly (DFMA) and Lean Manufacturing principles preferred.


    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.


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