Keld Schmidt

Senior consultant

Compliance | Engineering | Management | Personal

Summary

Keld has a wide range of competences acquired through more than 35 years of experience from Product development, electronics engineering in life science projects and in the renewable energy sector. He has taken roles as VP electronics, R&D Manager, QA Manager, Team lead, project manager, senior electronics designer. Keld has been responsible for bringing products to market in Medtech start-ups, managing product design, product approval, documentation, implementing QMS systems. Keld has been responsible for managing R&D development teams in both small and larger companies.

Special Competences

Management: Supervising, Product management, Lean product development, Team lead
Engineering: IEC60601, Electrical safety, EMC, verification & validation, General electronics, Power supply, System Architecture
Compliance: Product certification, ISO13485, ISO9001/14001, APQP, QMS SOP/WI
Personal
Problem solving, collaboration, engagement structured.

Project Experience

Hardware Development Manager
Hardware design lead of MRI and PET scanner patient motion tracker. IEC60601
Certification of tracking system.
eQMS evaluation project ISO13485 management.
Product documentation management.