@archishak brings up very good points, but I would also add that which option is chosen for cost estimation should also depend on the state of your organization at the time of pitching the project. Co...

There is also the matter of long term effect of choosing one vs multiple vendors. If there is a need to change the DSD anyways and alter the project timeline, then the drawbacks (design changes, time)...

Another strategy can be in holding stand-up meetings to keep track of every team member's task. This will ensure that critical tasks are being completed in a timely manner and that nothing is off-trac...

A good tool for ensuring that all knowledge areas are synced and properly coordinated is the Work Breakdown Structure (WBS). This tool allows the project manager to keep track of all the workstreams, ...

The scope is largely defined by the budget and target product release timeline. For example, the original scope for the project in the initial planning phases may require a 6 year launch timeline, how...

Most significantly, a WBS shows 100% of the project, as in it shows every aspect, from the overall project top-level objectives, to the breakdown of tasks, to the team member responsible, to the budge...

Most larger medical device companies have developed an 'Approval Matrix' that details out every potential type of change and document category (ex. change to material spec, process spec, risk document...

An important aspect of a project to monitor is project risk. At the start of the project a risk register is created with the potential risks, severity levels, and mitigation plans. Throughout the proj...

There are many strategies to try to resolve the conflict and discrepancies in understanding between the project lead and upper management, as described in the replies above. One important thing to con...

Validation is not required when the customer need is self evident. For example, if the customer need is for a sterile device, no validation test is required since the sterilization is documented as pa...

As @shahil mentioned, setting up rules in your email to sort is a great tool for keeping your email organized. There are a few ways to do this:creating a folder for every team member so that you can r...

@torikul Agree with all the above but especially wanted to highlight your point about running pilot studies. As a working engineer, I have seen projects dismiss holding a pilot for the sake of 'saving...

In this week's simulation, an orthopedic company with a small Biologics division partnered with an external expert on growth factors to develop a product that would boost the Biologics division revenu...

In this week's simulation, one of the most critical aspects to successfully determining which experiments to run and how to design the experiments involved asking the right questions. A basic skill ta...

Hi everyone! My name is Nora Moustafa and I am an R&D Engineer at Ethicon, Johnson & Johnson. Looking forward to connecting: