Steffen Eschinger
Senior Project Manager
Experience
Jul 2023 - Jan 2024
7 monthsSection 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 monthsCEO
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 monthsWorkstream 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 monthsHead 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 yearHead 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 monthsPsychotherapist
- 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
18 years 11 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 monthHead 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 monthsProject 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 yearsHead 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 yearsHead 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 yearsHead 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.
Languages
German
Native
English
Advanced
Education
Oct 1998 - Jun 2000
University of Bradford
Master of Business Administration · Strategic Management & Finance · Bradford, United Kingdom
Oct 1994 - Jun 1999