Engineering Project Playbook

"Systems thinking applied to project delivery."

A curated collection of frameworks, templates, and tools for Technical Program Managers (TPM) and Systems Engineers. Designed for high-complexity environments: Hardware + Firmware + Mobile App + Compliance.

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🎯 Purpose & Philosophy

To bridge the gap between abstract engineering requirements and business execution.

This playbook is built for engineers and managers who deliver products in regulated environments (e.g., MedTech, Automotive) where "move fast and break things" is not an option—instead, we must "move deliberately and fix things."

It serves two purposes:

1. A Knowledge Base: Reusable templates (Agile/Waterfall, Risk, V&V) designed for global standards (ISO 13485, FDA, MDR).
2. A Real-World Narrative: A retrospective on how these methodologies were applied in a specific Class II Medical Device project ("PFM").

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📂 Repository Structure

This repository follows a "Template + Evidence + Narrative" three-part structure:

• Template: Reusable, general-purpose documents.
• Evidence: Artifacts from the real "PFM (Pelvic Floor Muscle Rehabilitation Device)" project.
• Narrative: Contextual explanations of why certain decisions were made.

Engineering-Project-Playbook/
├── 01_Charter_and_Definition/      # 📌 Phase 1: Definition
│   ├── template_system_reqs.md
│   ├── evidence_pfm_scope.md
│   └── narrative_charter_decisions.md
│
├── 02_System_Architecture/         # 🏗️ Phase 2: Design
│   ├── template_interface_contract.md
│   ├── evidence_pfm_topology.md
│   └── narrative_make_vs_buy.md
│
├── 03_Planning_and_Execution/      # ⏱️ Phase 3: Execution
│   ├── template_hybrid_process.md
│   ├── evidence_pfm_gantt.md
│   └── narrative_vendor_strategy.md
│
├── 04_Verification_and_Validation/ # ✅ Phase 4: V&V (Deep Dive)
│   ├── template_traceability_matrix.xlsx
│   ├── evidence_pfm_test_report.md
│   └── narrative_vnv_challenges.md
│
├── 05_Compliance_Framework/        # ⚖️ Phase 5: Compliance
│   ├── template_risk_management.xlsx
│   ├── evidence_pfm_risk_table.md
│   └── narrative_audit_prep.md
│
├── 06_Tools_and_Automation/        # ⚡ Efficiency Tools (Python)
│   ├── python-automation/    # Data parsing, report helpers, misc scripts
│   └── jira-workflow/        # Workflow automation for program ops
│
└── 07_Case_Study_Project_PFM/      # 📖 The Narrative
    ├── README.md             # The complete "0 → 1 → Regulatory Clearance" story
    └── artifacts_map.md      # Index linking to evidence artifacts above

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🚀 Featured Case Study: Project PFM

To demonstrate the playbook in action, I have documented the complete lifecycle of Project PFM—a Class II Pelvic Floor Muscle Rehabilitation System (Biofeedback & Stimulation) delivered for NMPA clearance.

Key Engineering Challenges

• Real-time Integration: Synchronizing high-frequency EMG signals from MCU to Mobile App via BLE with minimal latency.
• Safety Criticality: Implementing rigorous electrical stimulation risk controls (Hardware limits + Firmware watchdogs) per IEC 60601-1.
• Holistic V&V Strategy: Orchestrating end-to-end verification (Unit → Integration → System) to ensure IEC 62366 usability compliance and robust HW/SW interoperability.
• Regulatory Traceability: Bridging the gap between Agile software iterations and IEC 62304 documentation requirements.

👉 Read the Full Retrospective Here

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🧱 Architecture & Standards

A breakdown of the technology stack and compliance framework implemented in Project PFM:

System Architecture

• Embedded: ARM Cortex-M (No-OS), Custom high-precision ADC/DAC driver, Watchdog safety logic.
• Connectivity: BLE 5.0 with custom GATT profiles for real-time waveform streaming.
• Mobile & Cloud: Native App with "Offline-first" architecture.
  • Local: SQLite for training data persistence and real-time rendering.
  • Cloud: Lightweight REST API (Python) for user account management and data backup/sync.

Compliance & Standards (NMPA/ISO)

The project strictly followed the Class II medical device pathway:

• Quality & Risk:
  • ISO 13485 (QMS)
  • ISO 14971 (Risk Management)
• Safety & Performance:
  • IEC 60601-1 / GB 9706.1 (Electrical Safety)
  • IEC 60601-1-2 / GB 9706.102 (EMC) & IEC 60601-2-10/ YY 9706.210 (Nerve Stimulators)
  • ISO 10993 (Biocompatibility) & GB/T 14710 (Environmental Reliability)
• Software & Usability:
  • IEC 62304 (Software Lifecycle - Class B)
  • IEC 62366 (Usability Engineering)
• Radio:
  • SRRC (China Radio Regulation) / Bluetooth SIG

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👨‍💻 About the Author

Shaun

• Role: Technical Program Manager / Systems Engineer
• Focus: MedTech, Cloud Infrastructure (AWS), AI Applications
• Philosophy: "Compliance as Code" — Automating the boring stuff so we can focus on engineering.

Contributions: Contributions and improvements are welcome — especially templates for risk, V&V, system architecture, or regulatory workflows.

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License: MIT