Steffen Eschinger - Senior Project Manager

Frankfurt am Main, Germany

Experience

Jul 2023 - Jan 2024

7 months

Section Manager EMEA, Item Master Medical Products MDR and FDA 820 part 21

Olympus SE

Responsible for data quality of approximately 100,000 medical devices in EMEA
Disciplinary authority over 15 full-time equivalents (FTEs) across two teams and one shared service center located in two countries
Cross-functional responsibility for the regulatory and commercial quality of medical product data in EMEA. Serving as the business architect for Unique Device Identification (UDI) and Global Trade Item Number (GTIN) labeling processes
Process owner for generating new medical product datasets
Contribution to the global master data governance system, particularly for regulatory and quality item data of medical products, influencing MDR and FDA 820 part 21 master data quality

Jul 2022 - Jun 2023

1 year

Germany

Head of Project Management (DACH / Benelux)

Getinge Deutschland GmbH

Responsible for 30 Mio € installations of medical devices in operation room, ICU and hospital infrastructure
Functional authority for 20 FTE
Cross-functional lead of additional 10 FTE
Responsible for conformity of installation of medical products due regulatory and quality requirements
Responsible for pre & post calculation of all regional installation projects
Responsible for complaint management due to ISO 13485 and Quality Management System
ISO 13485 external audit preparation and assigned speaker in the ISO 13485 process audit for the process Installation of medical product in DACH
Direct customer contact responsible for installations and instruction of medical products
Legal authority for supplier orders and customer quotes
Supplier management of appr. 70 suppliers due to MDR and Quality Management System
Regulatory responsibility of compliant installation according to instruction for use in medical installations
Responsible for contract management with suppliers & customers

Apr 2022 - Jan 2023

10 months

CEO

Smartcanula LLC

Responsible for MDR & FDA 820 Part 21 submission program
Chairman of the board
Head of Quality – full ISO 13485 QMS
Head of Regulatory
Head of Finance
Successful QMS audit ISO 13485 with DEKRA NL as notified body with only one minor deviation
Responsible for full rework of the QMS System due to MDR and ISO 13485
Successful handover to main investor as new CEO according to business plan

Nov 2021 - Sep 2022

11 months

Workstream Lead Class 3 MDR Submission Neuro / Spine Surgical Instruments

Karl Storz

Responsible for MDR Submission Program due to ISO 13483, IEC EN 60601, ISO 14971
Process owner medical product development for appr. 300 medical devices
Member of the Steering Committee as Program Manager of a strategic initiative
Functional authority for 120 FTE & cross-functional lead of ~12 subprojects
Preparation and group lead negotiations with notified bodies TÜV & DEKRA
Lead of cross-functional definition of intended use descriptions
Tracking and auditing R&D development process based on V-model, verification & validation, sterilization process, BioCompatibility Testing
Implementation of aggregated and detailed Project in MS Project & responsible for Resource Management according to chapter 6 EN DIN ISO 13485
Preparation of design history file for FDA 820 Part 21 submission

Jan 2019 - Aug 2021

2 years 8 months

Head of Product Centre Heart Therapies

Xenios AG

Responsible for disciplinary & cross functional activities development of worldwide new pulsatile VA ECMO
Member of the management team
Responsible for product center budget (> 5 Mio €)
Disciplinary authority for 12 FTE
Program-manager R&D projects
Hard & software development incl. bench testing
Responsible for MDR Submission Program due to ISO 13483, IEC EN 60601, ISO 14971
Process owner internal & external training for clinical professionals
Responsible for in-center clinical support
Responsible for a global field safety notice and successful market relaunch of the class III device
Owner of therapy life cycle process icor
Resource owner product innovation icor program
Coordinator icor sales / marketing projects
Implementation of scrum into the icor program
Generation of IP (2 technical innovations, 2 patents)

Jan 2018 - Dec 2019

1 year

Head of Project Management for R&D and Organization

Xenios AG

Responsible for introduction of project management processes in R&D
Operations, Sales & Marketing, functional authority for all project managers >150 FTE
Project manager master data management / FMC go-life of all Xenios products in SAP sales
Implementation of project management tools Planview and Projectplace
Process owner of SOP project management & overall resource management

Jun 2015 - Nov 2021

6 years 6 months

Psychotherapist

Clinical Assessment: Conducting thorough psychological evaluations to diagnose neurotic disorders and states of exhaustion
Individualized Treatment Planning: Designing and implementing personalized therapeutic interventions
Psychoeducation: Educating patients about their conditions, underlying causes, and potential coping strategies
Therapeutic Interventions: Applying evidence-based psychotherapeutic techniques
Progress Monitoring: Regularly evaluating patient progress and adjusting treatment strategies
Multi-disciplinary Collaboration: Working collaboratively with other healthcare professionals
Continuous Professional Development: Keeping updated with the latest research and therapeutic techniques
Patient Advocacy: Supporting and advocating for patients' needs and rights
Crisis Intervention: Providing immediate therapeutic intervention in acute situations
Aftercare Planning: Designing post-treatment support and resources
Personalized Nutritional Counseling and supplement recommendations

Apr 2006 - Present

19 years 2 months

Frankfurt, Germany

General Manager/CEO

Eschinger Consulting GmbH

Responsible for P&L
Disciplinary authority for up to 15 FTE
Responsible for overall business success of diverse projects
Identifying strategic business opportunities

Medtech Consulting:

Providing Market Data & Reimbursement Consulting
Medical Product Engineering
Development of go-to-market strategies

Strategy Consulting and Interim Management Projects:

Analysis of business performance
Development of business strategies and KPI Systems

IT Consulting:

Technical innovations in multidimensional database
Development of management information systems with SAP, MS-Navision, IBM, Oracle, Microsoft SQL/BI
Master data management projects

Trainer for medical products law, medical devices ordinance, commercial law, compliance, risk management & negotiation skills

Mar 2004 - Mar 2006

2 years 1 month

Head of Category Management & Project Manager Due Diligence Supply Chain

SMS Plastics Technology Group

Functional authority 15 FTE for 12 companies in the corporate group and 25 million euro spend
Due diligence for supply chain of all 12 companies in preparation for selling the group

Jan 2002 - Feb 2004

2 years 2 months

Project Manager for E-Commerce and Supply Chain Controlling

MAN Holding

Strategy development e-commerce MAN Group wide
Technical and operational leadership of data integration of all spend data for MAN companies in one data warehouse
Introduction of category management in the MAN Group
Technical development of a management information system & change management to implement operational controls & procedures

Jan 1998 - Dec 2002

3 years

Head of Planning and Controlling

MAN Roland Druckmaschinen

Responsible for spend and material planning & controlling for 4 plants
Disciplinary authority for 3 FTE and 40 million euro spend as controller
Accountable for development of e-commerce strategy for the MAN Group
Team leader of cross-functional strategy development team

Jan 1997 - Dec 1999

3 years

Head of Category Management for IT & Facility Management

Schott Glas and Carl Zeiss

Functional authority 20 FTE for 35 companies in the corporate group and 70 million euro spend

Jan 1994 - Dec 1999

5 years

Head of Technical Purchasing

Schott Glas

Disciplinary authority for 12 FTE and 20 million euro spend

Summary

Passionate leader with 20+ years of experience in guiding and expanding businesses.
Success-driven attitude with a proactive and hands-on approach to team leadership and sales management.
Broad-based knowledge across both technical and commercial aspects of medical products.
Master of Business Administration complemented by diverse range of qualifications suitable for steering a growing enterprise.