Principal Manufacturing Engineer
$82,100–$127,050 year
On-siteNorfolk, Nebraska, United States
Job Summary
Design and implement process improvements to reduce product cost, cycle time, and quality issues while managing capital projects and equipment validations. Lead continuous improvement initiatives for manufacturing equipment, including designing, testing, and writing specifications for new tools and vendors. Troubleshoot production equipment problems related to efficiency and scrap, develop corrective action plans, and coordinate new product start-ups across operational departments. Perform daily check-ins on assigned lines, conduct root cause analyses, and ensure compliance with FDA regulations, GMP, and OSHA standards. Manage project budgets, create cost-saving schedules, and lead safety activities including inspections and hazard reporting.
Required Qualifications
- Bachelor's degree in related field
- 4+ years of experience in related field
- Previous injection molding experience
- Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs and process validations
- Experience with Six Sigma and Lean Manufacturing tools
- Understanding and application of mechanical, electro-mechanical, electrical, pneumatic and hydraulic technologies and equipment
- Ability to read, analyze and interpret common scientific and technical information, financial reports and legal documents
- Experience with PLCs, HMIs, vision systems and instrumentations
- Ability to plan, organize, and prioritize projects to meet deadlines
- Strong communication, interpersonal, and problem-solving skills
- Detail-oriented with a commitment to accuracy and quality
- Collaborative team player with the ability to work independently and contribute effectively to team goals
- Compliance with statutory responsibility under the national/federal regulations
- Follow established EH&S procedures and policies
- Complete and remain up to date on required EH&S training
- Follow all ISO 13485, GMP, OSHA and plant/corporate standards, policies, and procedures
- Observe all safety precautions and regulations at all times in all areas where duties are performed
- Report all safety incidents, hazards, and potential unsafe working conditions
- Wear hair net, beard net, safety glasses and hearing protection
Desired Qualifications
- Bachelor's degree in related field, or equivalent work experience, preferred
- 4+ years of experience in related field preferred
- Previous injection molding experience preferred
- Understanding of FDA regulations surrounding the manufacturing of medical devices, GMPs and process validations would be an asset
- Experience with Six Sigma and Lean Manufacturing tools preferred
- Understanding and application of mechanical, electro-mechanical, electrical, pneumatic and hydraulic technologies and equipment preferred
- Ability to read, analyze and interpret common scientific and technical information, financial reports and legal documents
- Experience with PLCs, HMIs, vision systems and instrumentations preferred
- Ability to plan, organize, and prioritize projects to meet deadlines
- Strong communication, interpersonal, and problem-solving skills
- Detail-oriented with a commitment to accuracy and quality
- Collaborative team player with the ability to work independently and contribute effectively to team goals
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