Project Engineer, Medical Device Manufacturing & Validation

RXinsider LTD.; Holdrege (NE); On-site; USD 90,000 - 130,000; Full time

Job summary

embecta Nebraska is seeking an Engineering Project Manager to drive capital and non-capital projects that improve plant safety, quality, delivery, and cost. You will own projects from concept through validation and a smooth production handoff while coordinating with suppliers and internal teams.

The role emphasizes design, testing, FAT/SAT/IQ/OQ/PQ validation, and thorough documentation. A bachelor’s degree in engineering and 3+ years in manufacturing are preferred.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Three+ years in a manufacturing setting, engineering field.
• High-speed manufacturing experience preferred.

Responsibilities

• Deliver capital and non-capital engineering projects supporting plant safety, quality, delivery, and cost objectives.
• Lead projects through concept, design, build, test, validation, and production handoff.
• Serve as engineering owner for assigned projects.
• Design, specify, and validate manufacturing equipment and tooling.
• Lead FAT, SAT, IQ/OQ/PQ, and equipment validation.
• Coordinate cross-functional teams to meet project milestones.
• Communicate project status, risks, and results to stakeholders.

Skills

Mechanical design

Manufacturing systems design

Equipment specification

CAD

Manufacturing processes

Problem solving

Communication

Cross-functional teamwork

MS Excel

PowerPoint

Project management

SAP experience

Education

Bachelor’s degree in Engineering or related field

Tools

MS Project

SAP

Job description

embecta Nebraska is seeking an Engineering Project Manager to drive capital and non-capital projects that improve plant safety, quality, delivery, and cost. You will own projects from concept through validation and a smooth production handoff while coordinating with suppliers and internal teams.

The role emphasizes design, testing, FAT/SAT/IQ/OQ/PQ validation, and thorough documentation. A bachelor’s degree in engineering and 3+ years in manufacturing are preferred.