Project Engineer

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 is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, anda commitmentto improving lives, we are expanding our portfolio of solutions to serve even morepatients, healthcare providers, and communities around the world.

Essential functions include but are not limited to:

1.0 Core 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

2.0 Engineering & Technical Execution

• Design, specify, and validate manufacturing equipment and tooling
• Develop and test new manufacturing technologies and materials
• Support new product development and prototype builds
• Lead technical problem solving and root cause investigations
• Conduct equipment design reviews and risk assessments

3.0 Project Management

• Develop project scope, schedules, and cost estimates
• Track timelines, budgets, and resources
• Prepare capital requests and manage approved funding
• Coordinate cross-functional teams to meet project milestones

4.0 Vendor & Cross-Functional Collaboration

• Serve as liaison to equipment and material suppliers
• Manage vendor design reviews, FAT, installation, and startup
• Coordinate with manufacturing, quality, facilities, and maintenance teams

5.0 Validation & Change Management

• Lead Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), IQ/OQ/PQ, and equipment validation
• Implement and validate engineering changes and alternate materials
• Ensure compliance with internal procedures and regulatory requirements

6.0 Documentation & Communication

• Author technical documentation including machine specifications, validation protocols, capital requests, and test reports
• Communicate project status, risks, and results to stakeholders

OTHER FUNCTIONS (RESPONSIBILITIES) May Not Be All Inclusive:

• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
• Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other associates.
• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Associates will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
• Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty successfully.

EXPERIENCE & EDUCATION:

• Bachelor’s degree from an accredited college or university (engineering or related field) required

Or

• Three (3) or more years in a manufacturing setting, engineering field
• High speed manufacturing experience is preferred

SUPERVISION

• No direct supervision of others
• Indirect supervision over support personnel necessary for project completion including engineers, technicians, quality associates, facility associates, and equipment operators

KNOWLEDGE, SKILLS AND ABILITIES:

7.0 Technical Skills

• Mechanical or manufacturing system design
• Equipment specification, testing, and validation
• CAD (preferred)
• Manufacturing materials and processes

8.0 Project Management Skills

• Scope, schedule, and budget management
• Capital project planning and execution
• Resource coordination and risk management

9.0 Tools & Systems

• Proficient in MS Excel, PowerPoint, and Project (or equivalent)
• SAP experience preferred

10.0Professional Skills

• Strong problem-solving and analytical skills
• Effective verbal and written communication
• Technical documentation and report writing
• Ability to work independently and in cross-functional teams

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.