Verification is mostly paper work. All the design inputs such as specifications, government and industry regulations, knowledge taken from previous designs, and any other information necessary for pro...

When having a stern project stakeholder like Patty in the simulation, it is the project manager's duty to mediate any issues in concerns. Through clear communication and open-mindedness, the team shou...

As many have mentioned above, most company SOPs will not allow for any unethical activity to get around the FDA. And if a company decides to go against the policy, they will have to pay for the conseq...

This actually occurred in my team a few months ago. The previous PM got a new job with another J&J branch and one of the principle R&D engineers got promoted to becoming PM. So in our case, it...

Gantt charts are used to map out reasonable timelines including the initiation of a project and critical pathways, this way critical milestones can be monitored. The development of network diagrams an...

The planning phase is crucial in the project life as it sets the tone for the coming stages. You want to plan well so as to avoid any future complications. That is where risk management comes in to pl...

I think it's important to build in a discovery period for projects. Usually at the project kickoff meetings, stakeholders will immediately want to know what the final delivery date will be. This may n...

At the company I work for, one of the tasks I had to complete was to finish building a lateral compression tester used in our lab to test the firmness of breast implants. This second fixture was to be...

As a PM running a risk management meeting, I'd focus on defining risks instead of identifying risks and make sure everyone in the meeting is clear on them. I would have a top-to-down breakdown of the ...

At my company, design reviews are not as restricting as the capstone design review session. No one is forced to be silent while their project is being evaluated. There's more of a dialogue between the...

The role of project stakeholders is very valuable since there is always potential for positive and negative influence of one stakeholder over another. The greater the potential influence, the greater ...

The initiation phase is the hardest but most crucial part that sets the tone of the remaining phases for the given project. When you are pitching a new idea, you have to make sure it is presented succ...

This week is simulation week and our project is on Bottle Label Development for a Hydrophilic Coating Product. This got me thinking about package development for products and the types of test they mu...

It is very important to pick team members wisely. Depending on the types of projects your team covers, it's ideal to pick people who have qualities that your team may be lacking in and/or in need of. ...

Once you get a new medical device project, the first two things you should do is find out what the user needs are and establish a design plan. When going about user needs, what kind of questions do yo...