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James Saleh
@james-saleh
Trusted Member
Joined: Sep 5, 2025
Last seen: Apr 19, 2026
Topics: 0 / Replies: 63
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RE: Preplanning for Risk

I think the key is proactive planning and continuous monitoring. First, identify tasks on the critical path since they have zero float and identify th...

2 months ago
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RE: Hiring team members

I think the ideal and best answer is a balance of both but it really depends on the phase and complexity of the project. In medical device development...

2 months ago
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RE: Monitoring Time and Budget

If I were halfway through a project and noticed that both the Schedule Variance (SV) and Cost Variance (CV) were negative, I would first focus on unde...

2 months ago
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RE: Penalization for Going Over Budget and Time?

I do not believe penalties should be automatic. Accountability is important but the response should definitely depend on the root cause. If overruns a...

2 months ago
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RE: Team members personal issues with eachother

When personal issues arise between team members, I believe the project manager’s role is to protect both the team dynamic and the project objectives w...

2 months ago
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RE: Design Change Requests

One way to avoid this situation is by implementing a formal version control system with a single source of truth such as a shared drive with controlle...

2 months ago
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RE: Failed Verification Testing

Verification failure can be one of the most stressful phases of a project because it exposes gaps between the intended design and real world performan...

2 months ago
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RE: Business and customer satisfaction in project management

A project manager can align business needs with customer satisfaction by defining value from both perspectives at the start of the project. This is th...

2 months ago
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RE: Project Management Information Systems

One way is to tie reporting directly to value, not compliance. When team members see that their updates actually influence decisions such as workload ...

2 months ago
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RE: Design Input Document (DID) and Design Specification Document (DSD)

I think the main reason DID and DSD are kept separate is clarity and traceability. The DID defines what the device must do based on user, clinical, an...

2 months ago
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RE: What are challenges will we face if we missclassify a medical device ?

One major issue is regulatory noncompliance. Each device class (I, II, III) has different FDA requirements for testing, documentation, and approval pa...

2 months ago
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RE: Understanding your role...

I believe that projects are most effective when roles are clearly defined and a single team lead is established. Without clear ownership of tasks, gro...

3 months ago
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RE: Sizes of Project Teams

I have worked in both small and large teams, and found that team size really changes how decisions get made. Personally, I prefer smaller teams (3-6 ...

3 months ago
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RE: How would you handle team conflict as a Project manager?

If I were a project manager and my team was falling behind due to conflict, my first step would be to address the issue early and directly rather than...

3 months ago
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RE: How to communicate effectively between team mates in project team ?

One key way to communicate effectively in a project team is clarity and structure. Setting clear expectations early such as roles, responsibilities, d...

3 months ago
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