Michael Denzer Email & Phone Number

VP Client Relations @ EdgeOne Medical

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Michael Denzer Location

New York, NY, US

Michael Denzer Work

VP Client Relations @ (July 2025 - Present)
Head - Device and Packaging Engineering, Biosimilars @ (January 2023 - May 2025)
Vice President - Client Success @ (March 2019 - January 2023)
Sr. Director - Biologics Devices and Combination Product Development @ (October 2017 - March 2019)
Head - Device External Operations @ (September 2016 - August 2017)
Director - Commercial Devices and Combination Products @ (October 2015 - September 2016)
Mentor -Robotics Team 3637, "The Daleks" @ (August 2016 - May 2017)
Director - Device Development and Technology @ (July 2011 - June 2015)
Sr. Manager - Engineering - Packaging and Device Development @ (February 2007 - June 2011)
Principal Engineer - Packaging and Equipment Development @ (January 2004 - January 2007)
Engineer - Packaging and Assembly Equipment Development @ (January 1995 - January 2004)

Michael Denzer Education

New Jersey Institute of Technology
Bachelor of Science (BS) (Mechanical Engineering)
1995-1997

Michael Denzer Skills

Combination Products
Drug Delivery Systems
Parenteral
Packaging Engineering
Medical Devices
Cleanroom Manufacturing
Biologics
Pre-Filled Syringes
Auto-injector Development
Inhalation Product Development
FDA
Design Control
ISO 13485
Quality System
Regulatory Requirements
Product Launch
Human Factors Engineering
Drug Delivery
CAPA
Cross-functional Team Leadership
Syringe
Validation
Engineering
Manufacturing
Packaging
Technology Transfer
GMP
Pharmaceutical Industry
Product Development
Regulatory Affairs
Management
V
V&V
Biotechnology
Biopharmaceuticals
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Verification and Validation (V&V)
Development
Human Factors
Inhalation Product
Cross Functional Team
Verification And Validation V&V
Pre Filled Syringes
Corrective And Preventive Action Capa
Strategic Planning
Program Management
Cross Functional Team Leadership
Customer Service
U.S. Food And Drug Administration Fda
Auto Injector Development
Auto Injector
Device Development
Qualification
Electro Mechanical
Creams
Liquids
Device Design
Safety
Business Strategy
Combination
Core Technology
Usability Engineering
Testing
Pharmaceutics
Medicine
Connected Health
Forms
Mechanical Engineering
Master Plan
Assembly
Responsibility
Filing
Auto
Container
Rate
Applications
Functional Verification
Negotiation
Technology Evaluation
Injection Molding
Supplier Relationship Management
Facilities Management
Project
Start Ups
Final Assembly
Ep
Risk Management
International
Commercial Real Estate
Particle Size
Data Conversion
Troubleshooting
Spray
Molding
Inspiration
Initiation
Plastics
Facility Master Planning
Guidance
Trials
Direct Management
Marketing
Technical Aspects
Suppliers
Guidelines
Nasal
Distribution Center Operations
Patient
Design History
Patents
Design
Dry
Mechanical
Usability Testing
System
Rheumatoid Arthritis
Jersey
Sensors
Prototype
Autoinjectors
Technical Support
Regulatory Compliance
Aseptic
Tablets
Powder
Cascade
Cfr
Project Estimation
Aerosol
Closure
Fabricate
Isolators
Contract Engineering
Complaint Management
Inventory Control
Internal Controls
LCD
User Requirements
Operations
Multi Site Manufacturing
Training
R&d
Sub Assembly
Respiration
Alternate
Human Resources
Inspection
Justification
Strategy
Drafting
Delivery
ISO 14971
European Union
Image Capture
Technical Services
SQL
Microprocessors
Contract Management
Method Transfer
Product Transfer
Electronics
Injectable
Engineering Support
Due Diligence
Net
Stage
Connected Devices
Evaluation
Contract Manufacturing
Harmonization
Standardization
Commercialization
Public Speaking
Assembly Automation
CAP
Dosing
CMC
Supply
Platforms
Modification
Stakeholders
Contractual Agreements
Science
Insulin
Inhalation
Auditing
Qualify
Mechanics
Subcutaneous
Regulations
Class Ii
Concepts
Compliance
Remediation
Cost
Technical Operations
Internal Audit
Clinical Research
A2
Building Management Systems
Lead Development
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation

Michael Denzer Summary

Michael Denzer, based in New York, NY, US, is currently a VP Client Relations at EdgeOne Medical. Michael Denzer brings experience from previous roles at Civica Rx, Kymanox, Teva Pharmaceuticals and Shire. Michael Denzer holds a 1995 - 1997 Bachelor of Science (BS) in Mechanical Engineering @ New Jersey Institute of Technology. With a robust skill set that includes Combination Products, Drug Delivery Systems, Parenteral, Packaging Engineering, Medical Devices and more. Michael Denzer has 2 emails and 3 mobile phone numbers on RocketReach.