Job Description
Project Leadership & Equipment Integration
1. Lead or support NPI and equipment integration from concept through validation and ramp-up.
2. Manage project schedules, deliverables, and risks to ensure on-time, in-spec, and in-budget launches.
3. Plan and coordinate installation or transfer of equipment, including setup, qualification, and documentation.
4. Align cross-functional teams for DFM and smooth technology/equipment transfers.
5. Partner with Program Management, Quality, Operations, and Supply Chain on process readiness and issue resolution.
6. Support manufacturing readiness reviews and customer communications.
Process Design & Optimization
7. Develop, refine, and scale injection molding and assembly processes for quality, efficiency, and cost-effectiveness.
8. Apply Lean tools and data analytics to eliminate waste and reduce variability.
9. Lead cost-reduction and efficiency improvement initiatives.
Tooling & Equipment Management
10. Oversee specification, procurement, installation, and validation of molds, fixtures, and custom equipment.
11. Lead machine installation and qualification for production readiness.
12. Work with toolroom and vendors on tooling performance, modifications, and preventive maintenance.
13. Support mold qualification and ongoing reliability.
Documentation & Training
14. Create and maintain process documentation, including flows, work instructions, SOPs, and validation protocols.
15. Train operators and staff on new or updated processes.
16. Ensure documentation accuracy and compliance with quality and regulatory standards.
Compliance & Validation
17. Develop and execute IQ/OQ/PQ validations aligned with FDA, ISO 13485, GMP, and ISO 9001 requirements.
18. Ensure all processes meet regulatory, customer, and internal quality standards.
Cross-Functional Collaboration
19. Partner across Engineering, Quality, Operations, Supply Chain, and Tooling to support launches, transfers, and process readiness.
20. Participate in design reviews, DFM, and risk analyses.
21. Support customer discussions on manufacturability and validation status.
Continuous Improvement
22. Lead Kaizen and continuous improvement efforts.
23. Drive root cause investigations and implement CAPA.
24. Use statistical tools to improve capability and reduce scrap.
25. Promote a culture of problem-solving and innovation.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
Experience
26. 3-7 years of experience in manufacturing engineering or process development, preferably in medical device injection molding or other regulated industries.
Technical Proficiency
27. Strong understanding of injection molding, mold qualification, and downstream assembly operations (, ultrasonic welding, pad printing, packaging).
28. Hands-on experience with tooling design, equipment procurement, machine setup, transfers, and maintenance.
29. Proficient in process validation methodologies (IQ/OQ/PQ) and statistical analysis tools (Minitab, Gainseeker).
30. Skilled in process monitoring, data analytics, and root cause problem solving.
31. CAD experience required; simulation tools a plus.
32. In-depth knowledge of ISO 13485, ISO 9001, FDA, and GMP standards.
What's on Offer
33. Competitive salary ranging from $70000 to $110000 USD.
34. Comprehensive benefits package.
35. Opportunities for professional growth and development.
36. Be part of an innovative team in the industrial and manufacturing sector.
37. Work in an environment that values quality and efficiency.