Jaimie Cole

Jaimie Cole Email and Phone Number

Working on positively impacting a billion people over the next ten years. @ Principled Software Management
Rochester, NY, US
Jaimie Cole's Location
Rochester, New York, United States, United States
Jaimie Cole's Contact Details
About Jaimie Cole

Would you like to book a free consultation with me? Copy/Paste this link into your browser:https://calendly.com/principled-software-management/free-consultation My professional goal is to impact a billion people over the next ten years by helping companies choose the right People, Process, and Technology.My specialties are: Medical Device/Software Design Controls and Risk Management, Agile Software Development and Computer System Validation. I am well-versed in many different approaches to agile software development and have managed many successful software development teams. I have developed and defended software development life cycle processes for the healthcare/IT sector and can lead and advise on FDA regulations and guidances pertaining to medical devices and medical software development.One of my newer specialties is in Change Control Management for AI/ML SiMD and SaMD products. I can help with the validation of medical products that incorporate AI/ML and will require a Predetermined Change Control Plan (PCCP) for FDA approval.I can also help with Data Integrity, Data Protection, Data Privacy, and GDPR compliance.I have experience with the following regulations and standards: 21 CFR Part 820, 21 CFR Part 11, ICH E6(R3), IEC 62304:2015, ISPE GAMP5, ISO 13485, ISO 14971, ISO 60601, EMA 112288, EU MDR.I have experience configuring and using: Greenlight Guru, JAMA Software, Jira, Smartbear Zephyr.Reach out to me at: jaimie.software@gmail.com#agile #scrum #kanban #CSV

Jaimie Cole's Current Company Details
Principled Software Management

Principled Software Management

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Working on positively impacting a billion people over the next ten years.
Rochester, NY, US
Website:
principledsoftwaremanagement.com
Employees:
1
Jaimie Cole Work Experience Details
  • Principled Software Management
    Principled Software Management
    Rochester, Ny, Us
    View
  • Principled Software Management
    President
    Principled Software Management Sep 2019 - Present
    Rochester, New York, Us
    View
  • Atumcell
    Vp Of Product
    Atumcell Feb 2024 - Present
    Boston , Ma, Us
    View
  • Qmetrics Technologies
    Chief Information Officer
    Qmetrics Technologies Oct 2019 - Jun 2022
    Pittsford, Ny, Us
    View
  • National Science Foundation (Nsf) I-Corps
    Industry Mentor
    National Science Foundation (Nsf) I-Corps Sep 2019 - Nov 2019
    Alexandria, Va, Us
    I-Corps Mentors are advisors that have two primary roles. First, by being a third party resource for the team, the mentor can help the team recognize and reduce confirmation bias during the customer discovery process. In this role the I-Corps Mentor is in some ways an extension of the I-Corps Teaching Team in helping the team absorb and apply the relevant lessons. Second, the I-Corps Mentor should be someone that has industry contacts and knows the ecosystem of the target market area. I-Corps Teams will be interviewing more than 100 potential customers and potential partners in person. A good mentor can help the team find the right people to interview.
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  • Ert
    Sr Product Manager
    Ert Mar 2018 - Aug 2019
    Philadelphia, Pa, Us
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  • Icardiac Technologies, Inc.
    Vice President Of Technology
    Icardiac Technologies, Inc. Mar 2012 - Mar 2018
    Philadelphia, Pennsylvania, Us
    View
  • Icardiac Technologies, Inc.
    Senior Director Of Technology
    Icardiac Technologies, Inc. Feb 2010 - Mar 2012
    Philadelphia, Pennsylvania, Us
    View
  • Icardiac Technologies, Inc.
    Director Of Software Development
    Icardiac Technologies, Inc. Oct 2006 - Feb 2010
    Philadelphia, Pennsylvania, Us
    Responsible for all software development operations.Recruit and oversee staff of software architects, developers, testers.Establish and maintain software development lifecycle and processes.
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  • Rochester Institute Of Technology
    Adjunct Lecturer
    Rochester Institute Of Technology Aug 2014 - May 2016
    Rochester, Ny, Us
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  • Kodak
    Software Process Improvement Manager
    Kodak Feb 1999 - Oct 2006
    Rochester, New York, Us
    Describing and improving the entire software development lifecycle.Researching and applying improvement models such as CMM/CMMI and Agile.Managing a team of software process improvement professionals.
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  • Kodak
    Software Project Manager
    Kodak Mar 1992 - Oct 2006
    Rochester, New York, Us
    Elicit and analyze all software requirements.Lead the software design team in creating a robust architecture and high-level design.Produce a software project plan and assign appropriate resources.Manage and track the project plan to completion.
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  • Kodak
    Software Engineer
    Kodak Feb 1985 - Oct 2006
    Rochester, New York, Us
    Wintel programming experience: USB Device Drivers, TWAIN, image processing, installers.Real-time OS and embedded experience: pSOS TCP/IP, Motorola RMS68KExperienced with: : Microsoft Visual C++, Visual SourceSafe, InstallShield, Rational Rose, Clearcase, ClearQuest, RequisitePro, Rational Unified Process, Hitbox, Adobe Photoshop
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  • Kodak
    Software Development Manager
    Kodak Nov 1999 - May 2000
    Rochester, New York, Us
    Managed a team of software developers for Kodak's digital camera business.
    View

Jaimie Cole Skills

Software Development Agile Methodologies Cross Functional Team Leadership Agile Project Management Project Management Quality Assurance Strategy Product Development Leadership Software Project Management Sdlc Lean Software Development Software Design Product Management R&d Testing 21 Cfr Part 11 Commercialization Part 820 Software Quality Assurance System Architecture

Jaimie Cole Education Details

  • Rochester Institute Of Technology
    Rochester Institute Of Technology
    Computer Engineering

Frequently Asked Questions about Jaimie Cole

What company does Jaimie Cole work for?

Jaimie Cole works for Principled Software Management

What is Jaimie Cole's role at the current company?

Jaimie Cole's current role is Working on positively impacting a billion people over the next ten years..

What is Jaimie Cole's email address?

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What is Jaimie Cole's direct phone number?

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What schools did Jaimie Cole attend?

Jaimie Cole attended Rochester Institute Of Technology.

What are some of Jaimie Cole's interests?

Jaimie Cole has interest in Product Marketing, Project Management, Team Dynamics, Organizational Culture And Diversity, Leadership Development, Technology Transfer, Process Improvement, Digital Photography, Organizational Change, Lean/agile Software Development.

What skills is Jaimie Cole known for?

Jaimie Cole has skills like Software Development, Agile Methodologies, Cross Functional Team Leadership, Agile Project Management, Project Management, Quality Assurance, Strategy, Product Development, Leadership, Software Project Management, Sdlc, Lean Software Development.

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