Medical Devices, Program Management, project Manaement
Aktualisiert am 05.05.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 05.05.2026
Verfügbar zu: 100%
davon vor Ort: 100%
Programmmanagement
agiles Projektmanagement
PMP
Produktentwicklung
Qualitätsmanagement (Einführung...)
Supply Chain Management
Product Management
German
English
Hindi

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 years 5 months
2020-12 - now

Providing strategic leadership and operational oversight

Management Consultant: Medical Device & Pharmaceuticals
Management Consultant: Medical Device & Pharmaceuticals
  • Providing strategic leadership and operational oversight across innovation, R&D and manufacturing for medical devices and pharma.
  • Driving complex CAPEX programs and projects, managing suppliers, enhancing processes and guiding product management activities.
  • Building strong relationships with cross-functional teams, senior leadership, external partners, and regulatory bodies to align priorities while leading projects from concept through execution.
  • Key customers: SCHOTT Pharma, Roche, Mallinckrodt Pharmaceuticals 
Adpareo GmbH, Switzerland
4 years
2022-01 - 2025-12

quality assurance, and production to ensure effective stakeholder management

Senior Project Manager (External Consultant)
Senior Project Manager (External Consultant)
  • Headed a cross-functional team of 14+ engineers and directed collaboration with 6+ suppliers, quality and regulatory team for new product in R&D leading the full product lifecycle.
  • Acted as a chief liaison between sponsors, development teams, quality assurance, and production to ensure effective stakeholder management. 
SCHOTT Pharma AG, Sankt Gallen, Switzerland
2 years 6 months
2021-02 - 2023-07

Led development of structured learning solutions

Technical Documentation Expert
Technical Documentation Expert
  • Led development of structured learning solutions and compliant technical/customer documentation for medical devices (MDR, ISO 13485, GMP).
  • Collaborated with cross-functional SMEs (R&D, Quality, Regulatory, Service) to implement a centralized knowledge-sharing platform for technical documentation and training materials.
ROCHE DIAGNOSTICS GmbH, Penzberg, Germany
1 year
2021-01 - 2021-12

Spearheaded six concurrent technical workstreams

Project Manager (External Consultant)
Project Manager (External Consultant)
  • Spearheaded six concurrent technical workstreams, leading a multidisciplinary R&D team of 50+ professionals in the end-to-end development of a novel drug delivery platform.
  • Oversaw key technical decisions, resource planning, budgeting, timeline management, and risk mitigation to ensure project success. 
Mallinckrodt Pharmaceuticals, Dublin, Ireland
2 years 8 months
2018-04 - 2020-11

Program & Project Management

Freelance Consultant in Medical Device Development & Pharma
Freelance Consultant in Medical Device Development & Pharma
  • Program & Project Management, Risk Management, Quality, managing development, manufacturing & remediation projects.
LivaNova Deutschland GmbH, SCHOTT Pharma AG
10 months
2019-12 - 2020-09

Providing strategic leadership

Management Consultant (Validation)
Management Consultant (Validation)
  • Providing strategic leadership for process validation with Indian suppliers for SCHOTT.
  • Leading a 10+ member on-site team and driving cross-cultural stakeholder collaboration. 
SCHOTT AG, Mainz, Germany
1 year 11 months
2018-04 - 2020-02

remediation project for heartlung machine

Project Manager and Team Lead for Remediation Project
Project Manager and Team Lead for Remediation Project
  • Project Manager for a team of 12+ for a remediation project for heart-lung machine. Strategic oversight of budgets, resources, timelines, risks, and reporting while driving continuous improvement.
  • Working as a Quality Expert supporting new development establishing new processes, risk management, CAPAs and audit related activities. 
LivaNova Deutschland GmbH, Munich, Germany
1 year 9 months
2016-07 - 2018-03

Managing test method validation activities

Senior Consultant: Medical Devices
Senior Consultant: Medical Devices
  • Managing test method validation activities for drug-delivery systems for B. Braun, Melsungen.
  • Established a QMS system for a customer in Hamburg for development of surgical device for lens implantation. 
adjutem GmbH, Oldenburg, Germany
2 years 4 months
2014-03 - 2016-06

Handled multiple projects running in the field of respiratory devices

Project Manager
Project Manager
  • Handled multiple projects running in the field of respiratory devices, implants, biosensors, active medical devices for wound cleaning, drug delivery systems.
  • Project Management through complete project lifecycle leading a team along with clients and partners.
  • Risk Management analyzing technical risks during device development and Risk Management File. Handling Design History File in accordance with ISO 60601 to deliver high quality technical file.
HotSwap Lübeck GmbH, Lübeck, Germany
11 months
2013-04 - 2014-02

Supporting product management and risk management related activities

Development Engineer
Development Engineer
  • Supporting product management and risk management related activities for a respiratory device.
  • Development of new product including prototype construction.
  • Prepare Design History File in accordance with ISO 60601 to deliver high quality technical file. 
HotSwap Lübeck GmbH, Lübeck, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

2 years 1 month
2010-02 - 2012-02

Master in Biomedical Engineering (MSc.)

Fachhochschule Aachen, Germany
Fachhochschule Aachen, Germany
4 years
2005-09 - 2009-08

Bachelor in Biotechnology (B.Tech)

Amity Institute of Biotechnology, India
Amity Institute of Biotechnology, India

Kompetenzen

Kompetenzen

Top-Skills

Programmmanagement agiles Projektmanagement PMP Produktentwicklung Qualitätsmanagement (Einführung...) Supply Chain Management Product Management

Produkte / Standards / Erfahrungen / Methoden

Profile

Project Management Consultant with 12+ years of experience delivering complex CAPEX and product development programs across MedTech and pharmaceutical industries. Holds a Master?s degree in Biomedical, with strong expertise in GMP- and GxP-regulated environments, leading end-to-end project lifecycles including validation, technology transfer, and manufacturing scale-up. Proven ability to manage global cross-functional teams, supplier networks, and multi-million-euro budgets to ensure compliant, high-quality, and timely delivery. Experienced in stakeholder management, risk mitigation, and process optimization, with a solid track record of executing R&D and manufacturing initiatives for leading organizations such as Roche Diagnostics and SCHOTT Pharma. 


FUNCTIONAL SKILLS

  • Program Management
  • Project Management
  • Strategic Advisory
  • Stakeholder Management
  • Product Development
  • Supplier Management
  • Process Improvement 


SOFT SKILLS

  • Executive communication
  • High emotional intelligence (EQ)
  • Conflict resolution & negotiation
  • Strong organization
  • Ethical leadership
  • Collaborative team leadership 


IT SKILLS

  • MS PROJECT, Word, Excel, PowerPoint & Office 365
  • Jira
  • Solidworks
  • Origin 

Einsatzorte

Einsatzorte

Frankfurt am Main (+50km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 years 5 months
2020-12 - now

Providing strategic leadership and operational oversight

Management Consultant: Medical Device & Pharmaceuticals
Management Consultant: Medical Device & Pharmaceuticals
  • Providing strategic leadership and operational oversight across innovation, R&D and manufacturing for medical devices and pharma.
  • Driving complex CAPEX programs and projects, managing suppliers, enhancing processes and guiding product management activities.
  • Building strong relationships with cross-functional teams, senior leadership, external partners, and regulatory bodies to align priorities while leading projects from concept through execution.
  • Key customers: SCHOTT Pharma, Roche, Mallinckrodt Pharmaceuticals 
Adpareo GmbH, Switzerland
4 years
2022-01 - 2025-12

quality assurance, and production to ensure effective stakeholder management

Senior Project Manager (External Consultant)
Senior Project Manager (External Consultant)
  • Headed a cross-functional team of 14+ engineers and directed collaboration with 6+ suppliers, quality and regulatory team for new product in R&D leading the full product lifecycle.
  • Acted as a chief liaison between sponsors, development teams, quality assurance, and production to ensure effective stakeholder management. 
SCHOTT Pharma AG, Sankt Gallen, Switzerland
2 years 6 months
2021-02 - 2023-07

Led development of structured learning solutions

Technical Documentation Expert
Technical Documentation Expert
  • Led development of structured learning solutions and compliant technical/customer documentation for medical devices (MDR, ISO 13485, GMP).
  • Collaborated with cross-functional SMEs (R&D, Quality, Regulatory, Service) to implement a centralized knowledge-sharing platform for technical documentation and training materials.
ROCHE DIAGNOSTICS GmbH, Penzberg, Germany
1 year
2021-01 - 2021-12

Spearheaded six concurrent technical workstreams

Project Manager (External Consultant)
Project Manager (External Consultant)
  • Spearheaded six concurrent technical workstreams, leading a multidisciplinary R&D team of 50+ professionals in the end-to-end development of a novel drug delivery platform.
  • Oversaw key technical decisions, resource planning, budgeting, timeline management, and risk mitigation to ensure project success. 
Mallinckrodt Pharmaceuticals, Dublin, Ireland
2 years 8 months
2018-04 - 2020-11

Program & Project Management

Freelance Consultant in Medical Device Development & Pharma
Freelance Consultant in Medical Device Development & Pharma
  • Program & Project Management, Risk Management, Quality, managing development, manufacturing & remediation projects.
LivaNova Deutschland GmbH, SCHOTT Pharma AG
10 months
2019-12 - 2020-09

Providing strategic leadership

Management Consultant (Validation)
Management Consultant (Validation)
  • Providing strategic leadership for process validation with Indian suppliers for SCHOTT.
  • Leading a 10+ member on-site team and driving cross-cultural stakeholder collaboration. 
SCHOTT AG, Mainz, Germany
1 year 11 months
2018-04 - 2020-02

remediation project for heartlung machine

Project Manager and Team Lead for Remediation Project
Project Manager and Team Lead for Remediation Project
  • Project Manager for a team of 12+ for a remediation project for heart-lung machine. Strategic oversight of budgets, resources, timelines, risks, and reporting while driving continuous improvement.
  • Working as a Quality Expert supporting new development establishing new processes, risk management, CAPAs and audit related activities. 
LivaNova Deutschland GmbH, Munich, Germany
1 year 9 months
2016-07 - 2018-03

Managing test method validation activities

Senior Consultant: Medical Devices
Senior Consultant: Medical Devices
  • Managing test method validation activities for drug-delivery systems for B. Braun, Melsungen.
  • Established a QMS system for a customer in Hamburg for development of surgical device for lens implantation. 
adjutem GmbH, Oldenburg, Germany
2 years 4 months
2014-03 - 2016-06

Handled multiple projects running in the field of respiratory devices

Project Manager
Project Manager
  • Handled multiple projects running in the field of respiratory devices, implants, biosensors, active medical devices for wound cleaning, drug delivery systems.
  • Project Management through complete project lifecycle leading a team along with clients and partners.
  • Risk Management analyzing technical risks during device development and Risk Management File. Handling Design History File in accordance with ISO 60601 to deliver high quality technical file.
HotSwap Lübeck GmbH, Lübeck, Germany
11 months
2013-04 - 2014-02

Supporting product management and risk management related activities

Development Engineer
Development Engineer
  • Supporting product management and risk management related activities for a respiratory device.
  • Development of new product including prototype construction.
  • Prepare Design History File in accordance with ISO 60601 to deliver high quality technical file. 
HotSwap Lübeck GmbH, Lübeck, Germany

Aus- und Weiterbildung

Aus- und Weiterbildung

2 years 1 month
2010-02 - 2012-02

Master in Biomedical Engineering (MSc.)

Fachhochschule Aachen, Germany
Fachhochschule Aachen, Germany
4 years
2005-09 - 2009-08

Bachelor in Biotechnology (B.Tech)

Amity Institute of Biotechnology, India
Amity Institute of Biotechnology, India

Kompetenzen

Kompetenzen

Top-Skills

Programmmanagement agiles Projektmanagement PMP Produktentwicklung Qualitätsmanagement (Einführung...) Supply Chain Management Product Management

Produkte / Standards / Erfahrungen / Methoden

Profile

Project Management Consultant with 12+ years of experience delivering complex CAPEX and product development programs across MedTech and pharmaceutical industries. Holds a Master?s degree in Biomedical, with strong expertise in GMP- and GxP-regulated environments, leading end-to-end project lifecycles including validation, technology transfer, and manufacturing scale-up. Proven ability to manage global cross-functional teams, supplier networks, and multi-million-euro budgets to ensure compliant, high-quality, and timely delivery. Experienced in stakeholder management, risk mitigation, and process optimization, with a solid track record of executing R&D and manufacturing initiatives for leading organizations such as Roche Diagnostics and SCHOTT Pharma. 


FUNCTIONAL SKILLS

  • Program Management
  • Project Management
  • Strategic Advisory
  • Stakeholder Management
  • Product Development
  • Supplier Management
  • Process Improvement 


SOFT SKILLS

  • Executive communication
  • High emotional intelligence (EQ)
  • Conflict resolution & negotiation
  • Strong organization
  • Ethical leadership
  • Collaborative team leadership 


IT SKILLS

  • MS PROJECT, Word, Excel, PowerPoint & Office 365
  • Jira
  • Solidworks
  • Origin 

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