Product Engineering Awards

This phase occurs once the detailed design is complete, and prototypes are built with manufacturing-representative quality and detail. More extensive, formal testing is performed, such as life, reliability, safety, environmental, drop, and vibration.

The design team works closely with the manufacturing team to enable a smooth transfer, often with Simplexity engineers traveling to the contract manufacturer sites to ensure product quality. The design is transferred to the client based upon specific needs, most often after all tests are complete and the design is verified.

Typical deliverables:

Pre-production units
Formal verification test reports
Design transfer package, including Design History File (DHF) if needed for FDA submittal
Process validation support
Unit build tracking
Contract manufacturing schedule and budget
Quality metrics verification

Gate definition:

Design verification complete

Awards

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Phase 3: Design Verification And Design Transfer

Design & Engineering

Test: Design verification test

NPI

Quality: Quality metrics verification process, Process validation support

Typical deliverables:

Gate definition:

Phase 2C: Detailed Design Prototype 2

Design & Engineering

Test: Engineering confidence test, integration test

NPI

MFG. Readiness: CM onboarding Design transfer prep

2C. Prototype 2 Design, Build And Test

Typical deliverables:

Gate definition:

Phase 2B: Detailed Design

Design & Engineering

Test: Engineering confidence test, unit test

NPI

MFG: Readiness: Project build plan CM selection

2B. Prototype 1 Design, Build And Test

Typical deliverables:

Gate definition:

Phase 1: Requirements & Planing

Design & Engineering

Project Plan Requirements

ID/UX Concepts

Risk Analysis

Manufacturing Strategy Identification

Typical deliverables:

Gate definition:

Production

Design & Engineering

Manufacturing design guidance and ongoing engineering support

Ongoing quality metrics monitoring & optimization

Typical deliverables:

Phase 2: Detailed Design

Design & Engineering

Test: Characterization and qualification of high risk subsystems & components

NPI

2A. Architecture and Technology Feasability

Typical deliverables:

Gate definition:

Phase 0: Exploration

Exploration

Research

Concept Work

Architecture explorations

Feasibility study

Typical deliverables:

Gate definition: