BME-410-davidlin-2026-08-30-03-14-20

Identify and apply relevant engineering standards, regulations, and consensus guidelines as design inputs and constraints.

Lecture, homework, writing assignments, project

homework, writing assignments, project

Establish goals, tasks, and timelines for a project, following common industry project management practices.

Lecture, homework, writing assignments, project

homework, writing assignments, project

Produce engineering solutions that meet sponsor, customer, and end-user needs for project design, while considering practical constraints similar to those in real-world engineering projects.

Lecture, homework, writing assignments, project

homework, writing assignments, project

Produce project documentation using appropriate formats and grammar, adhering to discipline-specific conventions and engineering standards.

Lecture, homework, writing assignments, project

homework, writing assignments, project

Collaborate effectively with individuals from diverse backgrounds, skills, and perspectives, simulating real-world teamwork dynamics.

Lecture, writing assignments, project

writing assignments, project

Deliver well-organized, logical oral project presentations that accommodate audience interests and backgrounds, providing clear explanations when needed, similar to professional presentations in the industry.

Lecture, oral presentations, project

oral presentations, project

Make ethical judgments in situations involving project safety, intellectual property, data reporting, and other considerations, reflecting the ethical standards upheld in the professional world.

Lecture, writing assignments, project

writing assignments, project

Week 1

Main points of the syllabus. Expectations. Primary design motivation.

Lecture

Week 2

Problem Definition. Customer Need Documentation. Design constraints. Quality and Engineering Standards: Regulatory, Industry, Technical. In-class assignment to practice search and identification of technical standards relevant to each team's specific design.

Lecture, in-class activity

Homework

Week 3

How to create a successful team?

Lecture, in-class activity

Writing assignment

Week 4

Main principles of setting goals and objectives. S.M.A.R.T.

Lecture, in-class activity

Writing assignment

Week 5

Design theory and principles. Functional Analysis.

Lecture, in-class activity

Writing assignment

Week 6

GxP, GLP/GDP, SOP

Lecture, in-class activity

Homework

Week 7

Design Controls.

Lecture, in-class activity

Writing assignment

Week 8

Project Schedule. Program Evaluation and Review Technique (PERT), Gantt chart (GC). Building blocks and elements of PERT and GC - I

Lecture, in-class activity

Writing assignment

Week 9

Building blocks and elements of PERT and GC – II

Schedule risk assessment,

Lecture, in-class activity

Writing assignment

Week 10

Human Factor Engineering.

Lecture, in-class activity

Homework

Week 11

Design Input.

Lecture, in-class activity

Writing assignment

Week 12

Design verification/validation

Lecture, in-class activity

Writing assignment

Week 13

Risk management – 1. Hazard, hazardous situation, risk. ISO 14971:2019. Preliminary Hazard Analysis. FMEA. FTA. Risk analysis master record.

Lecture, in-class activity

Writing assignment

Week 14

Design Reviews

Presentations

Presentation

Week 15

Pre-Alpha prototype presentations

Presentations

Presentation, project report

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