Sebastian H.

NPI Engineer / Project Manager @ GN Group

About

Experienced Technical Engineer/Process Specialist/Project Manager with a demonstrated history of working in the MedTech industry. Skilled within quality assurance and leading both internal and global cross-functional projects. Stakeholder management and coordination roles across various in-house functions including; Product and Process Development, Production, Product Sustainment, Procurement, Marketing and Regulatory. This combined with specialist roles surrounded by; Process technology, Raw materials, Packaging/Sterile barrier systems(SBS), Suppliers, Documentation, Innovation and R&D. And this in both Technician, Engineer and Project leader roles.

Country

Denmark

City

Copenhagen Metropolitan Area

Industry

Medical Device

Skill

Teamwork, Ændringsstyring, Projektstyring, Plastmaterialer, Ingeniørarbejde, Kvalitetskontrol, SOP, Samarbejde, Dansk, Engelsk, Teknisk dokumentation, Teknisk uddannelse, Sparta Systems TrackWise Digital Cloud QMS, Injection Molding, FDA, ISO 13485, Medical Devices, Validation, CAPA, Root Cause Analysis

Experience

NPI Engineer / Project Manager

GN Group

2024-3 - Present · 2 yrs 7 mos

Denmark

Supplier Quality Engineer

Convatec

2021 - 2024-3 · 3 yrs

Sjælland, Danmark

Responsible for ensuring supplier compliance with Convatec’s quality standards and regulatory requirements (ISO13485/MDR, FDA/MDSAP, and GMP). Collaborated closely with cross-functional teams and led technical supplier issues, NC/CAPA handling, and Supplier evaluations for Management review. Apply LEAN techniques to drive continuous improvements and contribute to new product development and optimization projects. SME on SBS and processes.

Project Manager, Supplier & Product Sustainment

Cook Medical

2016 - 2021-2 · 5 yrs

Sjælland, Danmark

Project Manager, Supplier & Product Sustainment | Cook Medical Denmark | 2016- Med ansvar for; Lokal & global projektledelse, Vedligeholdelse af eksisterende produktportefølje (Post Market Surveillance Process), Kvalificering af alternative råvarer, Procesoptimeringer (Lean), Årsagsundersøgelser(Scar/CAPA), Sikre overholdelse af produktrelateret Regulatoriske standarder (EU MDR, 21 CFR part 820, ISO13485-2016,-/11607-/80369 mf.), Implementering af nye krav "Analysere standarder og myndighedskrav samt identificere aktiviteter, der skal være med til at eliminere eventuelle gaps" , Vidensdeling/Sparring til husets projekter (Senior Eng.)

Project Leader/Engineer, Supplier & Packaging, R&D & Manufacturing Eng

Cook Medical

2013 - 2016 · 3 yrs

Project Leader/Engineer, Supplier & Packaging, R&D & Manufacturing Eng. | 2013-2016 Med ansvar for; In/outsourcings projekter, Udvikling/Implementering af komplekse produktionsanlæg, sikre dokumentation, FAT/SAT test, Doe/validering/Dir/Risk, Modne-/implementere 3D Print teknologi i R&D, Innovation/procesteknologi, Sikkerhedsrepræsentant for R&D, Teknisk dokumentation samt Man.Eng, Interne/eksterne kvalitetsproblematikker (Leverandør issues, Fejlraporter, CAPA håndtering)

Engineer, Raw Matr, Proces & Packaging specialist, R&D/PTA

Cook Medical

2006 - 2013 · 7 yrs

Engineer, Raw Matr, Proces & Packaging specialist, R&D/PTA | Cook Medical Denmark | 2006-2013 Med ansvar for; Interne/eksterne kvalitetsproblematikker(CAPA), Leverandør udvælgelse samt godkendelse heraf, Alle tekniske leverandørrelateret kvalitetsproblematikker, Procesudvikling, Implementering af procesudstyr, Evaluering af emballagerelaterede standarder

Medical Device Packaging Engineer R&D/PTA

Cook Medical

2003 - 2006 · 3 yrs

Packaging Engineer R&D/PTA | William Cook Europe | 2003-2006 Med ansvar for; Design/konstruktion af sterilbarriere emballager, Alle kvalitetsproblematikker relateret til sterilbarriere/emballage, Procesudvikling, R&D relateret til packaging, Dokumentation, Test /validering, Løsning af kvalitetsproblematikker hos underleverandører.

Butikschef

EDEKA

1999 - 2001 · 2 yrs

Butikschef | Edeka Idestrup | 1999-2001 Med ansvar for; Daglig ledelse og drift/økonomi, Salgsledelse og salgsudvikling, Medarbejderudvikling, Værdier & kultur udvikling, Personaleledelse/Personaleudvikling(20 ansatte).