The Associate Equipment and Automation Engineer will provide front line operations support to the Engineering and Instrument Production team with documentation, quality system management and other support functions to ensure that automation systems and instruments are built to the highest quality manufacturing standards. This role will work cross functionally with various teams to manage the instruments and components throughout the product lifecycle. The Associate Equipment and Automation Engineer will be the primary liaison between the Instrument Production, Systems Development, Technical Services and Operations teams.
Essential Duties and Responsibilities
Manage product changes to ensure correct implementation into production, including but not limited to BOM, material routings, receiving inspection methods, manufacturing Work Instructions and Standard Operating Procedures (SOPs) in a Good Manufacturing Practices (GMP) environment.
Lead low complexity projects to improve production quality, capability, reliability, and/or reduce costs. Participate as a team member on more complex improvement projects.
Create, document and execute validation plans to support new, changing, or obsolescence of processes or parts.
Lead investigation of supplier part failures with help from the Supply Chain and Quality departments.
Accountable for triaging equipment failures, identifying root causes with support from experienced team members, resolving performance issues, and implementing corrective / preventative actions.
Initiate or support investigation of Non-Conforming Materials Reports (NCMRs) to resolve quality issues in a timely manner.
Support Supply Chain when transferring suppliers by providing technical expertise, validation requirements and executing testing protocols.
Identify appropriate Field Replacement Units (FRU), as well as release FRUs and related documentation for the service department.
Provide engineering support for the repair center, including tooling and procedures.
Support the build and testing of in-house automation equipment.
Maintain production processes and facilities in accordance with the FDA, QSR, and ISO 13485 medical device.
Possess a strong attention to detail including documentation skills required in a regulated environment.
Ability to communicate effectively within all levels within the organization, as well as with suppliers and customers.
Demonstrated ability to prioritize, plan, and drive multiple projects to completion through disciplined project management methodologies and tools.
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.
Ability to act with an inclusion mindset and model these behaviors for the organization.
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 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 grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
Ability and means to travel between local Exact Sciences Madison locations.
Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
Qualifications
Minimum Qualifications
Bachelor's degree in Engineering or field as outlined in the essential duties; or a High School Degree/General Education Diploma (GED) and 4 years of relevant experience in lieu of degree.
Demonstrated ability to understand engineering fundamentals and apply this knowledge to problem solve, troubleshoot, and improve processes.
Basic proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
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
Proficient at reading and interpreting the documentation of designs and production processes.
1+ years of experience with Enterprise Resource Planning systems (SAP), document control (Agile), and MS Office.
1+ years of experience with Solidworks.
1+ years of experience in product testing, calibrations, troubleshooting and problem solving.
1+ years of experience in software, robotic or PLC programming.
1+ years of experience using six-sigma and lean manufacturing tools.
1+ years of experience related to medical device manufacturing.
1+ years of experience with safety and health (OSHA), FDA and ISO 13485 quality system requirements.
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.
