Operations Engineer

EPTAM Plastics•Lakeville, MN

3d•$90,000 - $100,000•Onsite

About The Position

EPTAM Precision Micro-Machining is seeking an Operations Engineer for their Lakeville, MN facility. This role is crucial in supporting the creation of medical devices for OEM partners, focusing on life-saving parts and positive patient outcomes. EPTAM is a world-class manufacturer of custom medical device components, with a strong reputation in implantable components for orthopedic, cardiovascular, and other medical sectors. The company supports the Robot Assisted Surgery (RAS) and Minimally Invasive Surgery (MIS) industries. The facility operates under FDA and ISO 13485 standards, emphasizing a culture of quality and collaboration between Engineering, Quality, and Manufacturing Operations. EPTAM Solutions, the parent company, has nationwide locations and is committed to employee well-being and customer satisfaction.

Requirements

Bachelor’s degree in a technical discipline, Mechanical or Industrial Engineering preferred.
5+ years of relevant Mechanical or Industrial experience or training, or equivalent combinations of education and experience.
Demonstrated ability to execute the Essential Functions for this position.
Internships and PT experience are acceptable.
Working knowledge of Solid Works software.

Nice To Haves

Experience within a manufacturing environment is preferred but not required.

Responsibilities

Overseeing, reviewing, and implementing controlled processes to support departmental objectives.
Ensuring all process improvements align with the Company Quality Management System and are accurately documented.
Applying critical thinking and problem-solving skills across Operations, Quality, Engineering, Manufacturing, and administrative functions.
Providing day-to-day technical support for Operations, Quality, and Engineering to meet production goals.
Developing and updating manufacturing methods for new and revised production processes.
Preparing job packets, including travelers, operation details, drawings, customer correspondence, and fixture/tooling design specifications.
Analyzing production processes, schedules, and methods to recommend improvements.
Troubleshooting new or existing product issues related to design, materials, or processes.
Reviewing feedback, customer requirements, and completed jobs to identify areas for improvement.
Supporting the entry, coordination, and prioritization of Requests for Quote (RFQs).
Assisting in measuring components using advanced metrology tools (CMM, vision systems) and standard instruments.
Representing the company during customer, internal, ISO, and FDA audits.
Coordinating project workload in alignment with the manufacturing schedule.
Adhering to the Quality Management System and all documented procedures.
Conducting research and providing data on product and process improvements, considering scheduling, cost, and quality.
Alerting the Engineering Manager of potential deviations from established processes or standards.
Processing Engineering Change Orders (ECOs).
Updating Inspection Plans (IPs).
Supporting the development and execution of Equipment Qualification Plans (EQPs).
Performing root-cause analysis, including microscopic inspection and sorting of nonconforming product.
Tracking and reporting trends within part families and product types.
Training and supporting employees in new or updated processes, procedures, and Work Instructions.
Observing employees performing documented processes and providing feedback.
Evaluating departmental functions to identify and implement process improvements.