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MillenniumSoft Inc · 1 week ago

Manufacturing Engineer - Urgent Need (Onsite) Only Local Candidates

Columbus, NE

Full-time

Onsite

Mid Level

MillenniumSoft Inc is seeking a Manufacturing Engineer for a medical devices company. The role involves designing assembly and packaging equipment, developing process designs, and managing equipment development projects to ensure compliance with manufacturing standards.

Staffing & Recruiting

No H1B

Responsibilities

Design assembly and packaging equipment and create user requirements specifications (URS) that meet manufacturing standards

Develop and implement process designs for new equipment

Lead supplier relationships and external design teams for capital projects

Create/obtain detailed 3D models/2D drawings using CAD software

Optimize equipment designs for cost efficiency, changeover time, maintainability and manufacturability

Perform engineering analyses to validate and optimize designs

Lead medical manufacturing process technology initiatives across all sites and products

Manage equipment development projects from requirements through implementation and site acceptance testing (SAT)

Select vendors, manage procurement, and ensure successful equipment integration

Provide equipment and engineering cost inputs for business cases

Validate equipment designs meet safety and operational standards

Collaborate with suppliers on automation process optimization

Analyze process performance data from existing operations

Manage vendor contracts with procurement and legal teams

Develop innovative mechanical systems based on project requirements and industry standards

Create and maintain comprehensive design documentation including assembly instructions, bill of process, etc

Participate in design reviews and risk assessments

Build and maintain failure mode and effects analysis (FMEA)

Collaborate on prototype development and testing

Coordinate with electrical and mechanical engineers for system integration

Provide technical expertise during production issues

Ensure compliance with client quality policies, procedures, regulatory requirements and industry standards

Design equipment for efficient operations to meet production targets and quality standards

Ensure equipment uptime and serviceability

Deliver projects on time and within budget

Qualification

CAD softwareProcess designEquipment development3D modelingSupplier managementTechnical expertiseTeam collaborationProject management

Required