“I had the pleasure of working with Robert Steele at our 2nd Annual Medical Device Safety Monitoring & Reporting conference, Jan. 21-23, 2014 in Las Vegas. Robert was a wonderful addition to our conference, taking on multiple roles of being the conference chairperson and one of our top session speakers. Robert was the perfect Chairperson for the conference, with his extensive background and experience with regulatory agencies including Europe, FDA, PMDA and TGA and clinical study experience in the US, Europe, Middle East and Japan, he was able to create in depth discussions on key concepts being discussed throughout the conference. As a stand alone speaker, Robert led a session on how Quality Systems Impact the Post Market Surveillance of a Device and it was very interesting and well presented. Overall, Robert was an excellent speaker and I hope to work with him again in the future.”
About
As part of the dynamic leadership team at Colfax a multi-industry Corporation I am part…
Contributions
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You're facing stakeholder resistance to change. How can you navigate pushback using root cause analysis?
Change is always difficult for people. It involves taking on in many cases extra workload and requires engagement from all affected stakeholders. The earlier that change is communicated usually the better the acceptance. Resistance forces can be objectively assessed but often is of limited use in convincing stakeholders. I always feel that involvement should explain the reasons why change is needed at an early stage in any project as management by surprise always results in disengagement for folks. Look to leverage opportunities for the team to be actively involved in the selection implementation and follow phases. Selecting a project champion in the lower ranks of a team can be quite effective.
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Here's how you can effectively manage quality with project managers.
Understanding key project stages and way points is essential to deliver any project. This however is only part of the story. Any project needs to deliver the required outcome(s) with requirements meeting the specifications this applies to any project including process development and improvements or a material product based project. Understanding the quality aspects ensures not only a timely outcome but a satisfactory measurable outcome. Definition of key to quality and key to timeliness parameters helps the project manager to function effectively
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Here's how you can showcase your problem-solving skills during an R&D interview.
The initial steps on an R&D project are often the most critical elements user needs and requirements need to be unambiguous as possible. Often there is unrealistic expectations for timescales so time spent on critical path planning is a worth while investment. As you move into the concept and or detail design phases take the time to develop solid documentation such as risk analysis or stress analysis iteration is key. Also think clearly about the testing, verification and validation requirements. What are the critical test attributes.
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Here's how you can showcase your problem-solving skills during an R&D interview.
One particularly helpful approach is to give real examples of design solutions and process improvements but remember innovation often is hard to measure on a continuous basis and often it is more about evolution rather than revolution. Think about what experiences you have in the companies technology and tie those into the examples you give.
Activity
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I’m happy to share that I’ve obtained a new certification: AI and ML: Leading Business Growth Program from MIT Professional Education! Very…
I’m happy to share that I’ve obtained a new certification: AI and ML: Leading Business Growth Program from MIT Professional Education! Very…
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It's been a truly fun and productive few months since I joined #Seqera, and I couldn't be prouder to be a part of this company. We have ambitious…
It's been a truly fun and productive few months since I joined #Seqera, and I couldn't be prouder to be a part of this company. We have ambitious…
Liked by Robert Steele
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What an honor to have been recognized as one of the "250 Women in AI to Follow" by the Data Science Salon! Data Science Salon is dedicated to…
What an honor to have been recognized as one of the "250 Women in AI to Follow" by the Data Science Salon! Data Science Salon is dedicated to…
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Experience
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Education
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The Open University
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Activities and Societies: Chartered Mechanical Engineer Chartered Quality Professional Black Belt Trained Senior ASQ Member
Worked within Medical Device Industry most of my career
Recommendations received
1 person has recommended Robert
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Meet our July Leadership Spotlight, Guy Guglielmino! 💼 As President of #Enovis Recovery Sciences, Guy leads a team of talented professionals…
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Had an epic conversation with an epic man today! And as an unexpected surprise, Dr. Tosh James gave both Natali and me signed preprints of his new…
Had an epic conversation with an epic man today! And as an unexpected surprise, Dr. Tosh James gave both Natali and me signed preprints of his new…
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Nearly three years with NVision and working with the wonderful team at Texas College Bridge! Amazing how time flies!!
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#Gratitude After a very memorable and impactful 16 years, I’ve made an incredibly difficult decision to leave Stryker for a new challenge (more on…
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Ready to kick off day 4 at MedTech Summit in Brussels. We look forward to inspiring discussions and encourage you to visit us at our booth! Frank…
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Great event last week in the amazing Implement HQ - the previous Tuborg building. https://lnkd.in/dAbxckqz
Great event last week in the amazing Implement HQ - the previous Tuborg building. https://lnkd.in/dAbxckqz
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