BenjaminRofail

Forum Replies Created

RE: organizational skills for QC

A quality control engineer must have extensive knowledge of the product, the theories that make the product work, and the specifications of the product and its components. For example, in the case of ...

In forum Quality Control and Quality Assurance

7 months ago
RE: Emerging technologies and QA

Based on what I have seen, many companies are still shy of using AI. The efficiency and ease of AI is a double edged sword. It can take away jobs, and there are still inquisitions about accuracy. A si...

In forum Quality Control and Quality Assurance

7 months ago
RE: Quality To The Rescue

Quality assurance is the internal FDA of a medical device company. It is the first step in preventing complaints from returning from the field. For example, if a non conforming material is found on th...

In forum Quality Control and Quality Assurance

7 months ago
RE: Switching to a Regulatory Career

I have recently switched from an engineering role to a regulatory role, and there are obviously pros and cons to it. Roles in regulatory or compliance usually provide more flexibility to work from hom...

In forum Regulatory Basics for Medical Devices

7 months ago
RE: The people we shall encounter in the field

As someone who works for a medical device company, I have had my fair share of unique experiences in and outside of the office. Yes, people have different types of accents, different backgrounds, diff...

In forum Regulatory Basics for Medical Devices

7 months ago
RE: Balancing Innovation and Safety

From an external point of view, the FDA has the role of dictating the balance between innovation and safety. Between the three different levels of devices, there are guidelines that are already set in...

In forum Regulatory Basics for Medical Devices

7 months ago
RE: Skills to get into research

There are similarities and differences in the desired qualities of an engineer in the industry versus a researcher in academia. Both fields require expertise in knowledge, however, academia prefers gr...

In forum Pre-clinical Device Development

7 months ago
RE: Professors in Academia

It seems as there are mainly students participating in this, that most are speaking from personal experience, as will I. I have had professors who are research lab leads and are conducting innovating ...

In forum Pre-clinical Device Development

7 months ago
RE: Ensuring Biocompatibility in Medical Devices

As one of the professors in the biomedical engineering department at NJIT once said, "biocompatibility is not a real word". Obviously, it is a real word. He was trying to explain to his students that ...

In forum Pre-clinical Device Development

7 months ago
RE: Project Management Drives Changes

I believe it is imperative for a project manager to have appropriate social skills, and be able to communicate effectively. For what is a project manager, except one that manages projects? In fact, a ...

In forum Intro to Project Management

8 months ago
RE: Milestones Missed: Failure or Success?

Based on my limited experience in the industry so far, missing a milestone can be upsetting. However, there is always a lesson to be learned from missing a milestone. I believe a lesson learned is nev...

In forum Intro to Project Management

8 months ago
RE: Scope Management: Balancing Innovation and Constraints

I believe that innovation can include both adding to the process or removing from the process in order to achieve a better result. If an innovation can expedite the project, while still maintaining th...

In forum Intro to Project Management

8 months ago
RE: Onsite or Remote (Work)

The issue of on site versus remote work is one that I am currently dealing with. I believe that it is a case by case basis. For a quality engineer that does not visit the manufacturing floor, the work...

In forum Introduction to Medical Device Development

8 months ago
RE: Grades and GPA's in graduate education

From a young age, I was taught that good grades matter. The harder you study, the better your grade. Up until my undergraduate career, it seemed that all that mattered was grades. However, I was first...

In forum Introduction to Medical Device Development

8 months ago
RE: Academia or Industry Preference?

It is clear that both academia and the industry are fruitful and innovative parts of biomedical engineering. During my undergraduate career at NJIT, I was exposed to the realm of academia, where profe...

In forum Introduction to Medical Device Development

8 months ago
Page 5 / 5