Sebastian K. - Interim Project Manager and Project Management Consultant

Go to Website

Bönningstedt, Germany

Experience

Dec 2024 - Jul 2025

8 months

Hamburg, Germany

Project Consultant

Nexperia Deutschland GmbH

As-is analysis of the project management maturity of a 50–100 million EUR development program in the planning phase
Development of concrete recommendations to optimize project design focusing on the methodology, project structure, and organization
Support of the internal project management in the planning phase by establishing the project setup and creating the project manual

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
Introduction of project management standards such as budget and schedule planning, RACI matrix, and reporting
Creation and visualization of a "Drug Product Development" guideline for the development of radiopharmaceuticals

Sep 2023 - Dec 2023

4 months

Wieringerwerf, Netherlands

Project Coordinator / Agile Coach

Quest Photonic Devices B.V.

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

Jul 2023 - Apr 2024

10 months

Hamburg, Germany

Project Consultant

Nexperia Deutschland GmbH

Successful definition and implementation of project management design and setup for the planning and execution of a development program over 100 million EUR
As-is analysis of project management maturity according to the IPMA DELTA maturity model
Development of 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 business processes and identification of process gaps
Creation of the "House of Processes" for process grouping 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

Digitalizing 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 project methodology (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

Managing and monitoring compliance, investment, and strategy projects to ensure series production of Class I/IIa/IIb medical devices
Developing the project roadmap and strategy for the EMEA production site with a portfolio budget of €10–15 million per year
Leading the five-person central project management team
Guiding decentralized project managers in the sustaining project portfolio
Enhancing 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

Leading the "Design to Costs" organizational project to reduce manufacturing costs of existing products
Developing and implementing 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

Leading the 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
Managing program risks, tracking milestones, coordinating and facilitating global design and planning reviews
Defining the global regulatory strategy for existing products under MDR and FDA
Coordinating UX design according to IEC 62366

Jun 2017 - Mar 2021

3 years 10 months

Hamburg, Germany

Project Manager - Internal R&D Project

Olympus

Leading the 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
Conducting a Scrum-based agile pilot for product development, with a successful agile transition after over 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 > €500k and 5–10 team members
Project planning and control, risk management, and work package definition
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 > €1M and 5–10 team members
Applied the target costing method
Implemented Methods-Time Measurement for assembly in production
Conducted process validation according to 21 CFR 820, ISO 13485, 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 manufacturing line for mechanical instruments in general surgery (Class IIa/IIb) in a matrix organization with a project budget > €1M and 5–10 team members
Conducted design and process FMEAs
Procured manufacturing fixtures and tools
Carried out and coordinated process validation according to 21 CFR 820, ISO 13485, GHTF Process Validation Guidance

Jan 2004 - Dec 2006

3 years

Drachten, Netherlands

Industrial Mechanic - Equipment and Precision Mechanics

Neopost Industrie

Manufactured precision mechanical parts, assembled and verified prototypes
Designed, built, and assembled tools and fixtures for the production of letter opening systems and postage machines

Summary

After 12 years of permanent employment and over 15 exciting and successful years at OLYMPUS in the medical technology industry, I decided to take a new professional direction.

The goal: to take the next step personally and professionally. To get to know new products, topics, tasks, projects, and corporate cultures. It motivates me to bring people together, solve problems, and find new paths in project work to stay successful.

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

Expert in combining engineering and project management. Are you looking for an experienced professional who blends engineering expertise with structured project management? Whether in production or product development, I support you as an interim project manager or consultant in successfully delivering your projects.