Manufacturing Engineer
Novozen Healthcare LLC
CA, United States
Full-time
Title : Manufacturing Engineer
Location : Costa Mesa, California
Job Description : Responsibilities :
Responsibilities :
- Lead and manage OQPQ and TMV processes as the primary engineer.
- Oversee and guide cross-functional teams and shared resources to ensure project success.
- Develop comprehensive project scopes, action plans, and allocate resources efficiently.
- Collaborate with project engineers to execute tasks across various stages of project release, including new product introductions and sustaining engineering efforts.
- Review customer designs to ensure manufacturing processes and procedures are optimized and compliant.
- Conduct Design for Manufacturing (DFM) analysis, specifically for cable and wire harness sub-assemblies, and design associated tooling and fixtures.
- Evaluate current processes to identify opportunities for automation or advanced tooling implementation.
- Propose new materials (such as 3D printing) to improve processes, particularly within manual work environments.
- Design or modify CAD models for manufacturing tooling and fixtures.
- Develop detailed work instructions for both new and existing manufacturing processes.
- Collaborate with customers to refine designs, enhancing manufacturability through adjustments in pins, tolerances, and processes.
- Participate in customer meetings, providing expert insights on manufacturing processes and addressing Q&A.
- Perform equipment validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Provide general support for additional activities related to New Product Introduction (NPI) as required.
Qualifications :
- Background in both Project Management and Engineering.
- Strong communication skills, both written and verbal.
- Experience in interacting directly with customers, providing updates, presenting solutions, and driving project progress.
- Ability to work with key decision-makers, ensuring alignment and progress on project objectives.
- Skilled in prioritizing tasks, identifying critical issues, and organizing workload efficiently.
- Capable of leading projects and taking ownership of programs to ensure successful outcomes.
Experience :
- ISO 13485 : 5+ years (Required)
- Manufacturing : 5+ years (Required)
16 days ago