Associate NPI Engineer

1. Design for Manufacturing (DFM) & Design Transfer

· Review Designs: Analyze engineering drawings and 3D models during the development phase to identify potential manufacturing or assembly issues early.

· Provide Feedback: Recommend design changes to engineers that will make the product easier to build, reduce cycle time, or lower cost without compromising function.

· Manage Bill of Materials (BOM): Review the initial BOM for accuracy, ensure part numbers are correct, and verify that all components are available and approved for production.

2. Manufacturing Process Development

· Create Assembly Documentation: Write and illustrate clear Work Instructions (WI) or Standard Operating Procedures (SOPs) that production staff will follow.

· Design Tooling & Fixtures: Conceptualize and design the jigs, fixtures, and tools required to hold parts or guide assembly during manufacturing.

· Define Process Flow: Map out the physical layout of the assembly line and the sequence of operations to ensure efficient material flow and ergonomics.

3. Pilot Build Execution & Management

· Lead Build Events: Coordinate and supervise the Prototype, Engineering Validation (EVT), and Pilot (PVT) builds.

· Material Readiness: Ensure that all components, parts, and sub-assemblies are available and kitted correctly before the build starts.

· Hands-On Assembly: Often physically build units alongside technicians to understand the assembly challenges firsthand and train operators.

4. Data Collection & Issue Resolution

· Document Failures: Track all issues, defects, and failures that occur during the NPI builds.

· Root Cause Analysis: Investigate the source of failures (e.g., is it a bad part, a confusing instruction, or a poor design?).

· Drive Corrective Actions: Facilitate meetings between design, quality, and production teams to assign owners for each issue and verify that fixes are implemented before the next build phase.

5. Quality & Reliability Validation

· Develop Test Procedures: Work with Test Engineers to define functional tests that ensure the product works as intended at the end of the line.

· First Article Inspection: Ensure the first units off the line meet all customer specifications and regulatory standards.

· Process Validation: Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to prove the process is stable and repeatable (common in Medical Device industries).

6. Supply Chain & Vendor Interface

· Supplier Qualification: Visit or audit supplier facilities to ensure they can produce parts to the required quality and volume.

· First Article Approval: Review inspection reports from vendors to approve the parts they have manufactured for the first time.

7. Production Ramp-Up Support

· Train the Team: Educate production supervisors and line operators on the new processes and quality expectations.

· Evaluate SMED modules (Single Minute Exchange of Die) that provide efficient, safe and timely changeover of a product while developing the requirements for NPI. These are both time and quality based goals for the First Article when a changeover event occurs.

· Floor Support: Remain on the manufacturing floor during the first few weeks of high-volume production to immediately troubleshoot any "teething" problems.

· Monitor Yields: Track the First Pass Yield (FPY) and cycle times post-launch to ensure the product is stable and profitable.

Work Location: In person