Roland S.-Senior Technical Project Manager | Process Engineering | Medical Device Industrialization
Check rate
Experience
Aerosol Generator Technology – Industrialization Partnerships
Aerosol Generator Technology – Industrialization Partnerships
Engaged by a former technology partner to identify and approach potential partners for further industrialization and commercialization of its vibrating membrane nebulizer aerosol generator technology.
Bone Substitute Material – Product Development & Manufacturing Transfer
Bone Substitute Material – Product Development & Manufacturing Transfer
Led development of a modified bone substitute material based on an existing product concept. Coordinated implementation of the modification with an external manufacturing partner responsible for pharmaceutical-type manufacturing processes under cleanroom conditions.
Managed technical interfaces with external manufacturing and developed and implemented verification and testing procedures.
Catheter-Based Drug Delivery – Product Development & Technical Project Leadership
Catheter-Based Drug Delivery – Product Development & Technical Project Leadership
Transformed an early-stage product concept into a systematically developed medical device. Substantially redesigned the concept, including design and development of a specialized catheter application for intraoperative use.
Identified and qualified suppliers for plastic components and tubing. Developed test methods implemented in design verification and in-process quality control, while meeting applicable regulatory development requirements.
Subsequently assumed additional formal responsibility as Interim Project Leader, including project planning, budget management and coordination of internal and external partners, while retaining a strong technical focus.
Inhaled Drug Delivery – Technical Assessment, Testing & Strategic Partnerships
Inhaled Drug Delivery – Technical Assessment, Testing & Strategic Partnerships
Advised a biotechnology company on nebulizers, dry powder inhalers and nasal delivery approaches. Analyzed existing inhalation studies, proposed further investigations, and initiated, coordinated and evaluated testing with new external partners.
Identified a strategic nebulizer technology partner and supported related contract negotiations.
Drainage Catheters – Manufacturing Process Optimization & MDR Compliance
Drainage Catheters – Manufacturing Process Optimization & MDR Compliance
Prepared MDR-compliant technical documentation and conducted verification and validation investigations. Analyzed the entire manufacturing process, proposed improvements and optimized individual production processes.
Emergency-Care Drug-Delivery Device – Project Management
Emergency-Care Drug-Delivery Device – Project Management
Assumed additional formal project management responsibility for a parallel emergency-care drug-delivery device development project.
Inhalation Device – Technical Development Leadership & Technology Transfer
Inhalation Device – Technical Development Leadership & Technology Transfer
Held a leading technical role in development of an inhalation device, spanning device technology, aerosol generation, manufacturing-related development and regulatory requirements. Led technical work and coordinated suppliers and external development collaborations.
Identified and integrated a strategic technology partner into the program. Transferred technical know-how and supported the partner in establishing capabilities to develop and manufacture vibrating membrane nebulizer aerosol generators.
Antibiotic Bone Cements (Class III) – MDR, Verification & Validation
Antibiotic Bone Cements (Class III) – MDR, Verification & Validation
Conducted MDR gap analyses and prepared retrospective technical documentation. Independently performed investigations supporting design verification and validation, and prepared technical responses to deficiency reports from regulatory authorities.
Aerosol Technology Start-up – Technology Assessment & Strategic Mentoring
OttoBock
Analyzed a recently introduced agile product development process that was not functioning as intended. Assessed workflows and organizational structures with employees and decision-makers; initiated process changes, accompanied their implementation and trained the teams involved.
Usability Engineering – IEC 62366
Usability Engineering – IEC 62366
Supported usability engineering processes in accordance with IEC 62366.
Development Process & Organizational Optimization
Ottobock
Ottobock – Development Process & Organizational Optimization
Analyzed a recently introduced agile product development process that was not functioning as intended. Assessed workflows and organizational structures with employees and decision-makers; initiated process changes, accompanied their implementation and trained the teams involved.
Drug-Delivery Pump – Manufacturing Readiness & Production Planning
Drug-Delivery Pump – Manufacturing Readiness & Production Planning
Analyzed manufacturing requirements for the production start-up of a continuous drug-delivery pump (drug-device combination product), including manufacturing workflows, supplier management, technical specifications and schedules.
Medical Device Development Strategy & Regulatory Requirements
Seiko Epson
Seiko Epson – Medical Device Development Strategy & Regulatory Requirements
Developed an assessment of regulatory, quality management and product development requirements for Seiko Epson’s planned entry into medical devices. Defined the requirements and processes needed to establish medical device development capabilities.
Inhaled Drug Delivery Start-up – QMS Development & IT Support
Seiko Epson
Development of a business strategy for the market entry in Europe of a surgery device Establishing international co-operations and KOL relations for a surgery device Analysing the quality management and product development process of a large Japanese company Preparing German market entrance of a Japanese medical device International market and technology analysis “Water-Jet-Scalpel”
Automated Manufacturing – Technical Concept & Business Planning
Automated Manufacturing – Technical Concept & Business Planning
Developed the initial technical concept for an automated manufacturing project and prepared the associated business plan, forming the basis for an application for German federal government funding.
Independent Consultant
Roland Stangl Innovations
Technical project leadership, medical device and drug-delivery development, process and product optimization, manufacturing-related development, design transfer, regulatory interfaces and technology assessment. Selected assignments are detailed in the accompanying Project Portfolio.
Breath Simulator – Product Development & Commercialization
Breath Simulator – Product Development & Commercialization
Product and business development of a breath simulator; technical development, testing and commercialization activities.
Director Business Unit MICROrun
PARI Pharma GmbH
Developing and commercializing microfluidic solutions; responsibility for medical micropump activities (01/2007–09/2009).
Director Microtechnologies
PARI Pharma GmbH
Leadership of microtechnology development for vibrating membrane nebulizers, electronics and software; responsibility for series production of nebulizer heads, Regulatory Affairs, intellectual property and innovation management. Coordination of development, manufacturing and industrialization. In parallel: Director Business Unit MICROrun (10/2009–12/2010), developing and commercializing microfluidic solutions; responsibility for medical micropump activities (01/2007–09/2009).
Project Leader / Head of Technology Development
PARI GmbH
Led product development and manufacturing-process development for vibrating membrane nebulizers, including transfer into series production. Responsible for aerosol physics, numerical simulations and microtechnologies. From 2001, headed Technology Development and laboratories for aerosol physics, sensors and microsystem technology.
Software Engineer
ISE, Integrated Systems Engineering
Numerical simulation of microelectronic devices; project leadership for simulation of high-performance components.
Postdoctoral Research Fellow
University of Stuttgart
Co-founder
HSB-Systems GmbH
Consultant until 2007.
Research associate
University of Stuttgart and Universität der Bundeswehr Munich
Industry experience
See where this freelancer has spent most of their professional time.
Experienced in Healthcare, Manufacturing, Biotechnology, Professional Services, Pharmaceutical, and Information Technology.
Business area experience
See which departments and functions this freelancer has contributed to most.
Experienced in Product Development, Project Management, Production, Research and Development, Quality Assurance, and Information Technology.
Summary
More than 25 years of experience in medical device development, including R&D leadership, international project management, drug delivery and inhalation technologies, regulatory affairs and industrialization. Extensive experience at the interface between medical device and pharmaceutical development, from early product development through risk management, Design Controls, MDR/FDA compliance and commercialization. Since 2011 independent consultant and interim project leader for international medical device, pharmaceutical and start-up companies.
Skills
Respiratory Drug Delivery & Vibrating Membrane Nebulizers
Design Transfer, Industrialization And Series Production
Drug-Device Combination Products
Verification, Validation & Risk Management
Formulation-Device Interaction & Aerosol Performance
Mdr / Fda Design-Control Interfaces
Mdr
21 Cfr 820
Fda 510(K)
En Iso 13485
Din En Iso 14971
Iec 60601
Iec 62304
Iec 62366
Din En Iso 27427
Iso 20697
Iso 5833
Practical Application In Product Development, Risk Management, Development Documentation, Usability, Regulatory Gap Analyses, Deficiency Responses, Audits And International Approval Activities.
- Polarion
- Matrix Requirements / Risk Manager
- Azure Devops
- Miro
- Autodesk Fusion 360
- 3d Printing
- Ms Office
Languages
Education
University of Stuttgart
PhD · Numerical Aerodynamics / Fluid Mechanics · Stuttgart, Germany
Technical University of Munich
Mechanical Engineering, Aerospace Engineering · Munich, Germany
Certifications & licenses
BIO Advanced Business Development Course
EBD Group
General Management
St. Galler Business School
Flexible Manufacturing
Leonardo Group AG
Project Management
Kepner & Tregoe
Statistics
Experience
Global experience
Expertise
Qualifications
Profile
Frequently asked questions
Have questions? Find more information here.
Roland is based in Moosburg an der Isar, Germany.
Roland speaks the following languages: German (Native), English (Advanced).
Roland has at least 35 years of experience. During this time, Roland has worked in at least 23 different roles and for 9 different companies. The average length of individual experience is 2 years and 6 months. Note that Roland may not have shared all experience and actually has more experience.
Based on recent experience, Roland would be well-suited for roles such as: Aerosol Generator Technology – Industrialization Partnerships, Bone Substitute Material – Product Development & Manufacturing Transfer, Catheter-Based Drug Delivery – Product Development & Technical Project Leadership.
Roland's most recent position is Aerosol Generator Technology – Industrialization Partnerships.
In recent years, Roland has worked for Roland Stangl Innovations.
Roland is most experienced in industries like Healthcare, Manufacturing, and Biotechnology. Roland also has some experience in Professional Services, Pharmaceutical, and Information Technology.
Roland is most experienced in business areas like Product Development, Project Management, and Production. Roland also has some experience in Research and Development, Quality Assurance, and Information Technology.
Roland has recently worked in industries like Healthcare, Biotechnology, and Manufacturing.
Roland has recently worked in business areas like Product Development, Project Management, and Production.
Roland holds a Doctorate in Numerical Aerodynamics / Fluid Mechanics from University of Stuttgart.
Roland has 4 certificates. Among them, these include: BIO Advanced Business Development Course, General Management, and Flexible Manufacturing.
Roland is immediately available full-time for suitable projects.
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Calculated based on our freelancers’ daily rates as of 9 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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