Sebastian K. - Project Consultant

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Bönningstedt, Germany

Experience

Dec 2024 - Present

9 months

Hamburg, Germany

Project Consultant

Nexperia Deutschland GmbH

As-is analysis of the project management maturity of a €50–100 million development program in the planning phase
Developing specific recommendations to optimize project design, focusing on methodology, project structure, and organization
Supporting the internal project management team during the planning phase by setting up the project framework and creating the project handbook

Mar 2024 - Feb 2025

1 year

Heidelberg, Germany

Clinical Program Management

Full-Life Technologies HK Limited

Initiation, planning, and management of clinical programs for the development of radiopharmaceuticals in cancer therapy
Implementation of project management standards such as budget and schedule planning, RACI matrix, and reporting
Creation and visualization of a "Drug Product Development" guideline for developing radiopharmaceuticals

Sep 2023 - Dec 2023

4 months

Wieringerwerf, Netherlands

Project Coordinator / Agile Coach

Quest Photonic Devices B.V.

Coordinating and supporting the planning and execution of process validations in production
Defining the process validation strategy in compliance with requirements according to 21 CFR 820, ISO 13485, and GHTF Process Validation Guidance
Mentoring in setting up an agile product development

Jul 2023 - Apr 2024

10 months

Hamburg, Germany

Project Consultant

Nexperia Deutschland GmbH

Successfully defining and implementing the project management design and set-up for planning and executing a >€100 million development program
As-is analysis of the project management maturity based on the IPMA DELTA maturity model
Developing recommendations to raise the maturity level of a project-oriented organization

Feb 2023 - Apr 2023

3 months

Hamburg, Germany

Process Manager

Vantopia GmbH

Inventory of existing company processes and identification of process gaps
Creation of the "House of Processes" to group processes into management, core, and support processes
Implementation of an Office 365 SharePoint–based intranet as a document and process management system

Feb 2023 - Mar 2023

2 months

Emstek, Germany

Project Manager

Gasunie Deutschland GmbH

Digitization of the registration and deregistration process at gas network stations in a matrix organization with a project budget > €100k and 5–10 project team members
Setting up the project design and defining the approach model (hybrid project management)
Milestone planning and gate preparation for project approval

Apr 2021 - Dec 2022

1 year 9 months

Hamburg, Germany

Project Portfolio Manager - Sustaining

Olympus Surgical Technologies Europe

Steering and monitoring compliance, investment, and strategy projects to ensure serial production of Class I/IIa/IIb medical devices
Project roadmap and strategy planning for the EMEA manufacturing site with a portfolio budget of €10–15 million/year
Disciplinary management of the five-person central project management team
Functional leadership of the decentralized project managers in the sustaining project portfolio
Further development of project management standards and project governance
Part of the initial Agile Coach team

Sep 2019 - Jun 2020

10 months

Hamburg, Germany

Project Manager - Internal Organizational Project

Olympus

Organizational project "Design to Cost" to reduce production costs of existing products
Development and implementation of methods for applying target costing in product development

Mar 2018 - Sep 2020

2 years 7 months

Berlin, Germany

Program Manager - Global R&D Program

Olympus

Development and approval of an energy platform (Class IIa/IIb) for high-frequency surgery in a matrix organization with a project budget > €50 million and 50–100 project team members
Program risk management, milestone tracking, coordination, and facilitation of global design and planning reviews
Definition of the global regulatory approval strategy for existing products according to MDR and FDA
Coordination of UX design according to IEC 62366

Jun 2017 - Mar 2021

3 years 10 months

Hamburg, Germany

Project Manager - Internal R&D Project

Olympus

Development and approval of a cystoscope (medical device class IIa) for urology in a matrix organization with a project budget > €10 million and 30–40 project team members
Pilot project for agile product development based on Scrum; successful agile transition after > 40% project progress

May 2016 - Jan 2018

1 year 9 months

Přerov, Czech Republic

Project Manager - Internal R&D Change Project

Olympus

Change project to modify the product and packaging design of single-use high-frequency electrodes for the US market in urology and gynecology (Class IIb) in a matrix organization with a project budget over €500 k and 5–10 team members
Project planning and control, risk management, and definition of work packages
Support in preparing relevant 510(k) approval documentation

Aug 2014 - Jun 2017

2 years 11 months

Hamburg, Germany

Project Manager - Internal Investment Project

Olympus

Investment project to optimize the supply chain and reduce manufacturing costs in a matrix organization with a project budget over €1 M and 5–10 project team members
Use of the target costing method
Implementation of Methods Time Measurement for assembly in production
Conducting process validation according to 21 CFR 820, ISO 13485, and GHTF Process Validation Guidance

Nov 2011 - Jul 2014

2 years 9 months

Hamburg, Germany

Sub-Project Manager - Internal R&D Project

Olympus

Design transfer, development, and qualification of the production line for mechanical instruments in general surgery (Class IIa/IIb) in a matrix organization with a project budget over €1 M and 5–10 project team members
Performing design and process FMEAs
Procurement of production fixtures and tools
Conducting and coordinating process validation according to 21 CFR 820, ISO 13485, and GHTF Process Validation Guidance

Jan 2004 - Dec 2006

3 years

Drachten, Netherlands

Industrial Mechanic - Equipment and Precision Mechanics

Neopost Industrie

Manufacturing precision mechanical components, assembly, and verification of prototypes
Design, manufacturing, and assembly of tools and fixtures for producing letter opening systems and franking machines

Summary

After 12 years of permanent employment and more than 15 exciting and successful years at OLYMPUS in the medical technology industry, I decided to take a new career path.

The goal: to take the next step personally and professionally. To discover new products, topics, tasks, projects, and corporate cultures. I am motivated by bringing people together, solving challenges, and constantly exploring new approaches in project business to stay successful.

"With sustainable project management for long-term success!"

Expert in combining engineering and PM. Are you looking for an experienced specialist who combines engineering expertise with methodical project management? Whether in production or product development – I support you as an interim project manager or consultant in the successful execution of your projects.