At work, we have multiple projects going on simultaneously in R&D to enhance some of our product lines. One of the projects involved mixing in a different material to reduce the overall weight of the implant. Another project involved aimed at making the implant more smooth by altering the implant geometry slightly. It turns out making that slight…[Read more]

In my experience, the procurement process is very straight forward but can sometimes be expensive. There have been several occasions where I have found a given product for a relatively cheap price but because it’s not on the approved vendor list for my company, I’m forced to place a PO from a more pricey vendor. We have an office administrator…[Read more]

Agreeing on the project goals is crucial to get the project up and running. If the whole team is not on board, you can’t continue with the project without it failing or just not producing good quality results. Effective communication is needed to make sure everyone is on the same page on working towards on goal in completing the project…[Read more]

Another way to keep track of a project’s progress is through team meetings in which the whole team gets filled in on each member’s status within the project. Typically, team meetings will go over what has been completed, what is being worked on currently, and what else needs to be done. Lead times can be discussed for the future task so everyone…[Read more]

I have had to modify CAD drawings to accommodate new design changes. This involved changing the rev number, adding redlines, and adjusting the bill of materials (BOM). Once the redlines drawing was approved, I had to go back and remove all strike-throughs and red font text and replace it with all black font with the final revision indicated in a…[Read more]

Like cdj24 mentioned, it’s hard to say which situation is better without knowing the context of the project and the company. Ideally, having a positive SV and CV is preferred but that’s not always possible. If the schedule is flexible to allow some variance while keeping the project under budget, this is not the worst case scenario. If the budget…[Read more]

In my experience, some factors that affect schedule variance negatively involves accounting for unplanned events. Recently we had to complete competitive testing on implants in comparison to our own implants. We had to complete implant characterization but the motors on one of our testing fixtures started stalling. Turns out, the motors were…[Read more]

Depending on the need to outsource, there are a lot of factors a PM needs to consider when picking a third-party vendor. The PM must consider whether the task at hand is a primary service that the company offers. If not, time should not be wasted on it. The PM must consider if there may be a competitive advantage to do the job at hand in-house.…[Read more]

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 proper function are compared with the design outputs such as drawings, assembly instructions, test instructions, and electronic design files. The…[Read more]

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 should be able to tackle any issues that may arise efficiently. Also, team members should be professional by being open-minded to hear out the reasonings…[Read more]

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 consequences. This is why it’s always a good idea to overestimate rather than underestimate when it comes to project timelines. As PM, you should build in…[Read more]

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 wasn’t a huge shift in that the new PM was someone who was already on the team for several years so they did not have to get up-to-speed with where the team…[Read more]

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 and gantt charts allows smooth initiation, continuation, and completion of a project according to the general project path flowchart. This is not only…[Read more]

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 play so you can execute the project plan as smoothly as possible. Of course there may be setbacks along the project life but the planning phase should…[Read more]

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 not always be attainable especially in the case of complex projects so expectations need to be set efficiently during the discovery period in which…[Read more]

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 shipped to our R&D team based in California so that they could also run the same tests as us instead of shipping implants to us solely to get test…[Read more]

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 risk sets with room for flexibility depending on how the meeting is going. After each risk set is presented, I would establish “next steps” with the…[Read more]

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 team and the one who is evaluating the project idea. We’ve had design review sessions with different department managers such as the marketing and…[Read more]

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 risk reach project goals. Knowing the weight of each stakeholder can help in focusing on the stakeholders’ needs, avoid risks, promote good…[Read more]

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 succinctly with minimal room for doubts/questioning. One should make sure that they have all the background research ready and solid claims to back the…[Read more]