Operations Engineer to join our team in
Lakeville, MN. Join us as we create medical devices that support our OEM partners in creating life-saving parts and positive outcomes for their patients.
Benefits Include:- Professional Development/On the Job Training
- Health and Wellness Benefits
- Clean, Friendly, Safe work Environment
- Recognition and Rewards Program
- Tuition Re-imbursement
- Competitive Pay/Merit Increases
- 401k w/ Company Match
- Employee Assistance Program (EAP)
POSITION SUMMARY: The Operations Engineer is primarily for the following:
The Operations Engineer is responsible for overseeing, reviewing, and implementing controlled processes to support departmental objectives. This role ensures that all process improvements align with the Company Quality Management System and are accurately documented through established procedures and training requirements. The Operations Engineer applies strong critical thinking and problem-solving skills across Operations, Quality, Engineering, Manufacturing, and administrative functions to maintain robust processes and systems.
ESSENTIAL FUNCTIONS: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
- Provide day-to-day technical support for Operations, Quality, and Engineering to meet production goals.
- Develop and update manufacturing methods for first-time projects and significant revisions to existing production processes.
- Prepare job packets, including travelers, operation details, drawings, customer correspondence, and fixture/tooling design specifications.
- Analyze production processes, schedules, and methods to recommend improvements to management.
- Troubleshoot new or existing product issues related to design, materials, or processes.
- Review feedback, customer requirements, and completed jobs to identify areas for improvement.
- Support entry, coordination, and prioritization of Requests for Quote (RFQs).
- Assist in measuring components using advanced metrology tools (CMM, vision systems) and standard instruments such as calipers and micrometers.
OTHER RESPONSIBILITIES:- Represent the company during customer, internal, ISO, and FDA audits as required.
- Coordinate project workload in alignment with the manufacturing schedule.
- Adhere to the Quality Management System and all documented procedures.
- Conduct research and provide data on product and process improvements while considering scheduling, cost, and quality factors.
- Alert the Engineering Manager of potential deviations from established processes or standards.
- Process Engineering Change Orders (ECOs).
- Update Inspection Plans (IPs).
- Support development and execution of Equipment Qualification Plans (EQPs).
- Perform root-cause analysis, including microscopic inspection and sorting of nonconforming product.
- Track and report trends within part families and product types to support accurate pricing and on time delivery.
- Train and support employees in new or updated processes, procedures, and Work Instructions to ensure proper understanding and consistent execution.
- Observe employees performing documented processes and provide feedback, including developing or revising Work Instructions as needed.
- Evaluate departmental functions to identify and implement process improvements.
EDUCATION AND EXPERIENCE:- EDUCATION: Bachelor's degree in technical discipline, Mechanical or Industrial Engineering preferred
- EXPERIENCE: 5+ years relevant Mechanical or Industrial experience or training, equivalent combinations of education and experience accepted OR demonstrated ability to execute the Essential Functions for this position. Internships and PT experience acceptable. Experience within a manufacturing environment is preferred but not required.
- Working knowledge of Solid Works software
ADP1495
