• Sustaining Engineer

    Job Locations US-WI-Madison
    Req No.
    2019-3775
    Category
    Research & Development
    Type
    Regular Full-Time
  • Summary of Major Responsibilities

    The Sustaining Engineer will ensure product support exists for installed base products of Exact Sciences instrument.  This position will be instrument production and services centric.   In this role, sustaining engineer will ensure that Exact Sciences instrument performance specifications can be maintained throughout the product lifecycle.   This position actively participates on Research/ Development and System Engineering projects teams to ensure instrument production and serviceability fulfill.  Sustaining Engineer interfaces daily with all elements of the Exact Sciences business.

    Essential Duties and Responsibilities

    • Maintain manufacturing work instructions for production personnel.
    • Assist Technical Services Engineer in identify appropriate Field Replacement Unit (FRU) and release FRU and related document for service organization.
    • Manage product changes (COs) to ensure correct implementation of changes into production.
    • Conduct review and disposition of Non-Conforming Materials Reports (NCMRs) to promote resolution of material issues, including the promotion of timely corrective action by the supplier(s).
    • Interface and support regulatory affairs as required to investigate an Out-of-Box (OOB) failures.
    • Maintain production processes and facilities in accordance with the FDA, QSR, and ISO 13485 medical device.
    • Maintain and assist with development of production fixtures and tooling.
    • Work with Laboratory Instrument Production Manager and Environment Health & Safety (EHS) Manager to implement special facility controls that may be required, such as Electrostatic Discharge (ESD), cleanliness, etc..
    • Document and control test processes, maintaining and developing same for low complexity processes.
    • Provide in-depth regulatory affairs support as required, e.g., supporting complaints investigation.
    • Provide engineering support for the repair center, including tooling and procedures.
    • Investigate field failures and feedback and identify root cause, research, suggest and implement hardware product enhancements that would improve field reliability of the product within the form/fit/function of the existing design.
    • Address part obsolescence and sourcing / redesign of obsolete parts through testing and documentation.
    • Plan for product lifecycle/obsolescence.
    • Support supplier transfers if needed (verified through first article and/or product testing).
    • Flexibility in schedule is required in this role to serve the needs of the customer or the organization. A traditional schedule will be the norm during most workdays.
    • Support and comply with the company’s Quality Management System policies and procedures.
    • Excellent oral and written communication skills, with strong attention to detail and record keeping skills required in a GMP environment.
    • Ability to work overtime as needed.
    • Ability to work a normal schedule Monday through Friday during normal business hours.
    • Regular and reliable attendance.
    • Ability to lift up to 40 pounds for approximately 5% of a typical working day.
    • Ability to work seated for approximately 90% of a typical working day Ability to work standing for approximately 10% 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 travel approximately 10% of working time.
    • Ability to comply with any applicable personal protective equipment requirements.
    • Frequent grasping and use of fine motor skills.
    • Occasional use of hazardous materials.
    • Other duties as required.

    Qualifications

    Minimum Qualifications

    • Bachelor’s degree in engineering or related field; or high school degree/general education diploma and 4 years of relevant experience in lieu of degree.
    • 3+ years of engineering experience working in manufacturing or engineering activities applying problem solving skills (e.g., Six Sigma, probability and statistics) and process improvement (e.g. Lean).
    • Frequently communicate with customers, and vendors in person, via the telephone or by email.
    • 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

    • Skills and aptitude to lead projects and coordinate work of others. Good written and verbal communication skills, with all levels of employees, suppliers, and customers.
    • Experience with personal computer systems, including enterprise resource planning (e.g. SAP, Oracle), web applications, MS Office, and Minitab is desirable.
    • Experience in writing, reading and interpreting the documentation of designs and production processes.
    • Experience using tools such as Agile and OrCAD.
    • Experience with constructional data forms and electrical standards.
    • Experience in product testing and calibration control processes, developing and using test equipment, troubleshooting and problem solving.
    • Experience in robotic, automation, and PLC.
    • Experience in ESD and cleanliness special control processes.
    • Medical device manufacturing experience.
    • Experience with safety and health (OSHA), FDA and ISO 13485 quality system requirements.

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

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