Hi everyone! Here is my LinkedIn page. Imarah Abdur Rasheed | LinkedIn (https://www.linkedin.com/in/imarahar/) I am currently a student at NJIT and look forward to connecting with you all!    Imarah Abdur Rasheed      

I would look to “Organizational Process Assets” to find procedures, guidelines, and existing information within the company. These assets include documented processes, policies, templates, lessons learned, and historical project information that help guide how projects are initiated and managed. They…   Read more»

As a project manager, my approach to handling personal conflicts between team members is to stay neutral and focus on how the situation affects the project, not the individuals involved. I would first address the issue early and privately by…   Read more»

I don’t think employees, group leads, or project managers should automatically be penalized for going over a deadline or budget, because so many factors in a project are outside of any one person’s control. Things like supply chain delays, rising…   Read more»

I believe regulatory considerations must be integrated from the very beginning of a project rather than treated as a final checkpoint before submission. As a project manager, I would involve regulatory experts at the concept and feasibility stage so they…   Read more»

If I were allowed to change the Design Specification Document, my approach would shift from simply adjusting the verification test to questioning whether the underlying design requirements truly reflect real-world use conditions and patient safety. While it might be tempting…   Read more»

As the project manager for a Class III bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

As the project manager for a Class I bio-absorbable vascular stent, I would see the animal study results as critical data rather than a setback, and I would pause the original strategy to reassess whether dissolving faster truly aligns with…   Read more»

I think the most important responsibility of the FDA is ensuring the safety of drugs and medical products before they reach the public. This is important because people rely on medications and medical devices to improve or protect their health,…   Read more»

I think both small and large teams have their pros and cons. Personally, I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without too much back-and-forth. I also find that working with…   Read more»

I agree that internal and external factors can really shorten or extend a product’s life cycle, especially in tech-driven fields like medical devices. In addition to verification and validation, I think tools like risk management (such as hazard analysis), post-market…   Read more»

@ms2768 I think your perspective is really interesting, especially since you’ve experienced both fully in-person work during the pandemic and now a hybrid setup. I agree with you that in-person meetings often feel more productive because people are less likely…   Read more»

I would prefer to work under a project manager who communicates mainly in person because face-to-face interaction makes expectations clearer and helps prevent misunderstandings. Being able to read body language and tone also helps build trust and makes feedback feel…   Read more»

I prefer working in a small team because it’s easier to communicate, stay organized, and make decisions without things getting slowed down. Everyone’s role is usually clearer, and it’s harder for people to get lost or disengaged. That said, I…   Read more»

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generating ideas and identifying possible risks from different perspectives, but I find FMEA to be the most beneficial…   Read more»

At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a company called MedTech Labs that develops diagnostic equipment. During testing, a technician accidentally spills a sample…   Read more»

I definitely believe risk management is an essential part of the planning phase. It’s not a waste of time or money; it’s actually a smart investment that can prevent much bigger losses later on. By identifying potential risks early, teams…   Read more»

I think the four columns in the Design Matrix, inputs, specifications, validation, and verification, provide a strong foundation, but they might not be enough to capture the full scope of the design process. I would recommend adding columns for risk…   Read more»

I think our current design control systems have definitely come a long way since the Therac-25 incident, but I’m not sure they’re strong enough to completely prevent a modern “Therac moment,” especially with the rise of AI-driven devices. Standards like…   Read more»