Kenneth Shipp

Medical Devices

Quality System

Design Control

Fda

Iso 13485

Cross Functional Team Leadership

Product Development

Product Launch

Manufacturing

Spine

Biomedical Engineering

Capa

Design of Experiments

Iso 14971

R&D

V&V

Validation

Design For Manufacturing

Fmea

Six Sigma

Lean Manufacturing

Minitab

Process Improvement

Root Cause Analysis

Dmaic

Quality Control

Continuous Improvement

Engineering

Spc

Biotechnology

Orthopedic

Manufacturing Engineering

Process Engineering

Surgical Instruments

Biomaterials

Gmp

Quality Management

Strategic Planning

Business Process Improvement

Failure Analysis

Product Design

Iso

Biomechanics

Business Strategy

Commercialization

Mechanical Engineering

Business Analysis

Employee Engagement

Gd

Gage R

Areas of Expertise GMPs for medical devices Manufacturing Process development Synthesizing clinical needs into design inputs Translating technology into customer value in a cost effective manner Ability to convert customer needs into marketable products Building effective working relationships with all levels both internal and external to the organization Project management and managing team dynamics Evaluating technical competencies in organizations and individuals Strategic planning Budget management Resource management Problem solving Leadership mentality Able to mentor

coach

and build future leaders Ability to think objectively and determine a course of action for what is required Ability to see future needs and responsibility both short-term and long-term Extensive knowledge of medical device industry Seeing the big picture and meeting company objectives Able to create and execute business strategies across functional departments Visionary

able to inspire and lead others Able to make difficult decisions Ability to manage resources short and long terms Well versed in clinical and regulatory affairs

quality systems regulations (QSRs)

and familiarity with the European Medical Device Directive EEC 93/42 relative to CE Marking.