Charles Booth Email & Phone Number

South Lyon, Mi, Us

Minneapolis, Mn, Us

Dexter, Mi, Us

Dexter, Mi, Us

Cambridge, Massachusetts, Us

Management of Engineering Department and project portfolio including sustaining and development of disposables and hardware devices, cold chain packaging, qualifications and validation. Responsibilities include improving and maintaining the automated ARS (Aastrom Replicell System) used in the manufacture of the biologic ixmyelocel-T.Responsible for Operations Engineering Department and project porfolio. Department responsibilites include calibration, maintenance, and monitoring for all equipment and facilities to meet GMP standards.Responsible for quality event resolution for all Engineering and OE department CAPAs, NCMs and deviations.

Management of the product development group, design control system, and project portfolio.Actively involved in Class I and II medical device engineering projects using Solidworks, rapid prototyping, rapid tooling, FEMAs, Design Reviews, and Validations.

Port Washington, New York, Us

Product Development Group - Over a decade of experience developing Class II medical devices from concept to production. Familiar with tools such as MS Project, Design Control, StageGate, DOE, Voice of the Customer and all aspects of conceptualizing, developing, and validating successful medical devices.Experienced using many plastic joining processes such as RF, laser, ultrasonics, luer fittings, solvent bonding, spin welding, and fusion.Familiar with developing solid processes for high speed automation including robotic assembly.

Bs, Biological Science

Bsme, Engineering