Extrusion Process Engineer

Location: Colorado

Department: Engineering

Reports To: Senior Engineering Manager / Director of Manufacturing

Company Overview:

Our client, a leading enterprise in the medical device manufacturing industry, dedicated to improving patient outcomes through innovative and high-quality medical solutions is seeking an Extrusion Process Engineer for their facility in Colorado. Their commitment to excellence drives them to continually enhance our processes and products, ensuring they deliver the best possible care to those who need it most.

Position Overview:

The Extrusion Process Engineer will play a critical role in optimizing and maintaining the extrusion processes used in the production of medical device components. This role requires a deep understanding of extrusion technology, materials science, and manufacturing processes, with a focus on achieving high-quality results, regulatory compliance, and continuous improvement.

Key Responsibilities:

1. Extrusion Process Management:

2. Develop, implement, and optimize extrusion processes for medical device components, ensuring alignment with production goals and quality standards.

3. Troubleshoot and resolve extrusion process issues, including equipment malfunctions, material inconsistencies, and process deviations.

4. Design and conduct experiments to improve extrusion processes, including developing new techniques and evaluating the impact of changes.

5. Quality Assurance:

6. Ensure all extrusion processes meet regulatory requirements and industry standards, including FDA and ISO guidelines.

7. Monitor and analyze extrusion process performance metrics, such as yield, consistency, and defect rates, to drive continuous improvement.

8. Collaborate with Quality Assurance teams to conduct root cause analysis and implement corrective actions for process-related quality issues.

9. Technical Documentation:

10. Create and maintain detailed process documentation, including process flow diagrams, standard operating procedures (SOPs), and work instructions.

11. Prepare and review technical reports, validation protocols, and process change documentation.

12. Equipment and Technology:

13. Oversee the installation, calibration, and maintenance of extrusion equipment to ensure optimal performance.

14. Evaluate and recommend new extrusion technologies and equipment to enhance production capabilities and efficiency.

15. Collaborate with equipment vendors and service providers to address technical issues and support equipment upgrades.

16. Cross-Functional Collaboration:

17. Work closely with R&D, Production, and Engineering teams to support new product development and scale-up activities.

18. Provide technical support and training to production staff on extrusion processes and best practices.

19. Participate in cross-functional project teams to address complex manufacturing challenges and drive process improvements.

20. Regulatory and Compliance:

21. Ensure all extrusion processes are compliant with relevant medical device regulations and standards.

22. Support regulatory audits and inspections by providing necessary documentation and addressing any process-related inquiries.

Qualifications:

• Education: Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related field. Advanced degrees or certifications (e.g., Six Sigma, Lean Manufacturing) are a plus.

• Experience: Minimum of 5 years of experience in extrusion process engineering, preferably within the medical device or pharmaceutical industry.

• Technical Skills: Strong understanding of extrusion technology, materials science, and manufacturing processes. Experience with medical device manufacturing standards (e.g., FDA, ISO) is highly desirable.

• Analytical Skills: Proficient in data analysis and statistical tools to monitor and improve process performance. Experience with process simulation and modeling software is a plus.

• Problem-Solving: Demonstrated ability to troubleshoot complex process issues and implement effective solutions.

• Communication: Excellent verbal and written communication skills, with the ability to collaborate effectively with cross-functional teams and present technical information to various stakeholders.

• Attention to Detail: Strong attention to detail and commitment to maintaining high standards of quality and regulatory compliance.

Working Conditions:

• This position may require working in a manufacturing environment with exposure to various machinery and equipment.

• Some travel may be required to support process implementation or equipment procurement.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.