Gregg V.

Gregg V. Email and Phone Number

Principal Systems Engineer (Design Assurance; Product Safety Risk Manager) @ Advanced Bionics
United States
Gregg V.'s Location
United States, United States
Gregg V.'s Contact Details

Gregg V. personal email

n/a

Gregg V. phone numbers

About Gregg V.

Perceptive, analytical, tenacious, driven, boundaryless team player. I solve intractable business problems. The more complex the problem, the more passionate I become about digging up the root cause and developing permanent solutions. I see systems and processes and understand how to guide a team to make improvements. With 9+ years’ experience working directly with senior management in designing and implementing strategic business change initiatives, I have established a reputation as the point person for attacking complex, mission-critical problems.My knack for problem solving began with systems analysis in the high technology field. I went on to design and lead the execution of biomedical research programs at 3 of the top 10 hospitals in the Greater Los Angeles area. My passion for and skills in scientific inquiry and team leadership led me to combine both in my current career as a process improvement expert, using the scientific method to understand situations and solve business problems.Examples of business transformation and continuous improvement accomplishments:► Used Six Sigma business analytics and kaizen to shrink processing time for past due orders by 50%. In the first three months of implementation, revenue increased by $1 million more than originally projected. ► Supported a 15-fold increase in production over 9 months through collaboration with stakeholders and applying kaizen and 5S events to optimize space utilization and process flow; reduced floor space 50% and eliminated 10 pallets of WIP weekly.►As change leader during a time of rapid growth, I transformed a unit from an environment of disengagement, lack of accountability, and broken processes to a high-performing, collaborative, team.“Gregg is an outstandingly intelligent, reliable, forward thinking individual who possesses a very well developed set of problem solving skills.” -- Thomas Troub, Program Manager, Medtronic Diabetes

Gregg V.'s Current Company Details
Advanced Bionics

Advanced Bionics

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Principal Systems Engineer (Design Assurance; Product Safety Risk Manager)
United States
Gregg V. Work Experience Details
  • Advanced Bionics
    Principal Systems Engineer (Design Assurance; Product Safety Risk Manager)
    Advanced Bionics
    United States
  • Medicept Inc.
    Sr. Software Quality Engineer
    Medicept Inc. Apr 2023 - Present
    Boston, Ma, Us
    MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.
  • Advanced Bionics
    Principal Systems Engineer (Design Assurance; Product Safety Risk Manager)
    Advanced Bionics Oct 2016 - Apr 2023
    Santa Clarita, Ca, Us
    ► Developed harmonized enterprise-wide risk management system to align methods for identifying, evaluating and managing safety, security, compliance and business risks across the organization.► Developed strategy to align risk management process with EN ISO 14971:2019 and EU MDR 2017/745.► Led risk management activities for three next-generation product lines.► Led design verification activities for a next-generation product line.► Developed post-market risk management surveillance system including data collection, analysis and reporting per ISO 14971, FDA and EU MDR requirements.
  • Beckman Coulter
    Product Safety Risk Manager
    Beckman Coulter Oct 2014 - Oct 2016
    Brea, California, Us
    ► Developed risk management remediation strategy to ensure conformance to EN ISO 14971:2012.► Led risk management teams for next-generation product lines.► Led risk management post-market surveillance activities.
  • Medtronic Diabetes
    Manager, Product Safety Risk Management
    Medtronic Diabetes Dec 2013 - Oct 2014
    ► Reporting to VP Quality, worked with senior leadership across the business to assess business need and gaps between current processes and future state system conforming to EN ISO 14971:2012, prioritized projects and managed teams to build a best-in-class risk management process.► Acquired talent and leveraged Lean Sigma expertise to build process and information systems; developed training program to train Quality and Engineering staff on state-of-the-art risk management and field action procedures for medical devices. ► Developed robust risk management and field action certification program.
  • Medtronic Diabetes
    Lean Sigma Black Belt
    Medtronic Diabetes Oct 2010 - Dec 2013
    ► I was hired to lead a team to resolve an intractable problem around inefficient order processing. Used Six Sigma business analytics and kaizen to shrink processing time for past due orders by 50%. In the first three months of implementation, revenue increased by $1 million more than originally projected. ► Developed process validation certification program to enhance engineering skills in the R&D, Operations and Quality teams and improve regulatory compliance. ► Supported a 15-fold increase in production over 9 months through collaboration with stakeholders and applying kaizen and 5S events to optimize space utilization and process flow; reduced floor space 50% and eliminated 10 pallets of WIP weekly.► As change leader during a time of rapid growth, I transformed a unit from an environment of disengagement, lack of accountability, and broken processes to a high-performing, collaborative, team.
  • Medtronic Diabetes
    Sr. Clinical Research Specialist
    Medtronic Diabetes 2007 - 2010
    Minneapolis, Mn, Us
    ► I was hired to develop and deliver a clinical research training curriculum to enhance understanding of clinical research strategies and processes, business acumen and improve regulatory compliance. By the end of the first year, I had delivered over 40 training opportunities to a rapidly growing department.► Tasked with improving over 50 clinical processes, I led teams to map the clinical value stream and identify kaizen opportunities. At the end of the second year, the number processes had been trimmed by 25% and 6 kaizens had been completed.► Worked with the clinical safety team to speed processing of adverse event reporting. Reduced process steps by 30+% and overall lead time 4-fold.► Led the kaizens and managed implementation of numerous improvements "in-the-business" and "on-the-business" of clinical research project management. Developed a stage-gate process to help management better understand and control execution of multiple concurrent clinical trials and process improvement projects.
  • City Of Hope
    Assistant Research Scientist/Fellow
    City Of Hope 2001 - 2007
    Duarte, Ca, Us
    ► I was hired to manage a complex research program investigating the roles of lipid-responsive nuclear receptors in regulating networks of gene expression in models of diabetes, heart disease and obesity.► Led cross-functional collaborations with Biostatistics, Microarray, Vivarium and other departments to identify target genes of nuclear receptors and drug candidates that activate gene transcription in models of obesity, diabetes and heart disease.► Managed and mentored research associates and interns in methods and techniques of drug discovery science.
  • Keck School Of Medicine
    Lab Manager/Doctoral Candidate
    Keck School Of Medicine 1997 - 2001
    Los Angeles, Ca, Us
    ► I was hired to manage operations of a major physiology laboratory, including budgeting and procurement.► My doctoral research program investigated intestinally-derived signals regulating the physiologic response to insulin insensitivity in various models of obesity and diabetes.
  • Cedars-Sinai Medical Center
    Cra Ii
    Cedars-Sinai Medical Center 1996 - 1997
    I was hired to design, execute and publish clinical trials of a novel, nutrient-based therapy targeted to improve food and drug absorption in patients with rapid gastrointestinal transit suffering from maldigestion and malabsorption.

Gregg V. Skills

Six Sigma Medical Devices Cross Functional Team Leadership Fda Leadership Iso 13485 Training Validation Lean Manufacturing Capa Clinical Trials Quality System Project Management Continuous Improvement V&v Design Control Program Management Clinical Research Design Of Experiments Change Management Quality Assurance Statistics Dmaic Kaizen Gmp Corrective And Preventive Action Verification And Validation Gxp Drug Discovery Medical Writing 5s Risk Management Operations Business Analysis Kaizen Facilitation Lean Assessment Medical Research Process Validation Team Motivator Research Project Management Science Writing Product Management Software Engineering Visual Basic Iso 14971

Gregg V. Education Details

  • University Of Southern California
    University Of Southern California
    Physiology & Biophysics
  • California State Polytechnic University-Pomona
    California State Polytechnic University-Pomona
    Human Nutrition
  • Norwich University
    Norwich University
    Chemistry; Bs Mathematics

Frequently Asked Questions about Gregg V.

What company does Gregg V. work for?

Gregg V. works for Advanced Bionics

What is Gregg V.'s role at the current company?

Gregg V.'s current role is Principal Systems Engineer (Design Assurance; Product Safety Risk Manager).

What is Gregg V.'s email address?

Gregg V.'s email address is gr****@****ics.com

What is Gregg V.'s direct phone number?

Gregg V.'s direct phone number is (661) 362*****

What schools did Gregg V. attend?

Gregg V. attended University Of Southern California, California State Polytechnic University-Pomona, Norwich University.

What are some of Gregg V.'s interests?

Gregg V. has interest in Systems Development, Change Management, Process Improvement, Wine And Cheese, Health.

What skills is Gregg V. known for?

Gregg V. has skills like Six Sigma, Medical Devices, Cross Functional Team Leadership, Fda, Leadership, Iso 13485, Training, Validation, Lean Manufacturing, Capa, Clinical Trials, Quality System.

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