Senior Safety-/Risk-Manager, System-Designer, Business Consultant
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- 55130 Mainz
- Weltweit
- de | en
- 20.01.2025
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
9/2021 – 6/2024
Tätigkeitsbeschreibung
- Overall HL system architecture, including electrical components, middleware, backend- and cloud-infrastructure, App design, voice control, data-flow, etc.
- Design and patent of new in-house localization function
- Design and patent of new UX functions
- HL Design of new electrical devices
Hardware-Design, Software Design, System Architektur, System Design
10/2020 – 9/2021
Tätigkeitsbeschreibung
New Hemodialysis Device
- Risk-Management for US 510(k) submission
- Responsible for Coverage Analysis of Risk-Mitigations
- Part of Anomaly Evaluation Board
IEC60601-x, ISO14971, IEC13485, FMEA, Polarion, Risk Management
DIN EN ISO 13485, FMEA (Failure Mode and Effects Analysis)
3/2020 – 1/2021
Tätigkeitsbeschreibung
Anemometry Flow Sensor Feasibility Study
- Design new flow sensor based on anemometry
- Evaluate use of such sensor to determine nasal air flow
System Design
1/2018 – 11/2018
Tätigkeitsbeschreibung
New Sensor Array for Cobot
- Based on Safe-PLC
- Certification process according to IEC61508
- Safety certification according to IEC13485 (PL c)
- System, SW architecture and certification consulting.
Requirements Management
2/2017 – 11/2017
Tätigkeitsbeschreibung
Increase reliability/availability of LTE/Wifi connection in ICE trains
- Analyze existing ICE multi-modem router (ICOMERA, ELTEC) and antenna setup
- Analyze modem switching and provider switching algorithm
- Analyze network availability
System Analyse
7/2016 – 8/2017
Tätigkeitsbeschreibung
Safety Platform for Rail Applications
- System software certification to SIL4
- Review and approval of all certification artefacts (HLRQ, SW-design, Low-level design, SW test specification)
- Migration plan for migrating to another QM process and approval with TUEV
EN50128, IEC61508, Functional Safety, QNX (RTOS), FMEA, Safety Monitoring, VectorCast
FMEA (Failure Mode and Effects Analysis)
1/2016 – 8/2016
Tätigkeitsbeschreibung
Investigational Medicinal Product Dossier for new Challenge Agent
- Consult with regulatory body through verbal and written scientific advices
- Select and validate GMP certified manufacturer
- Write IMPD for challenge agent
Klinische Forschung, Good Manufacturing Practices
1/2015 – 8/2016
Tätigkeitsbeschreibung
Technical and Clinical Validation of Mobile Particle Allergen Chamber
- Design technical validation and validation documentation according to regulatory body (Paul- Ehrlich-Institute)
- Support clinical validation team while consulting and reviewing clinical protocols, procedures and SOPs
- Consult with regulatory body through verbal and written scientific advices
- Setup clinical trials management system
- Consult on CFR 21 Part 11
- 21 CFR PART 820
Klinische Forschung, Good Manufacturing Practices
6/2014 – 12/2015
Tätigkeitsbeschreibung
RedEye – Evaluation System for Conjunctival Provocation Tests
- Design of a device to analyze the vasodilation of the conjunctivitis
- Design housing and mechanical setup
- Create and present Poster at AAAAI Meeting in San Antonio
- Create selection matrix for cameras
- Design UI
Klinische Forschung, Bildverarbeitung, Mechanische Systeme, Projektmanagement (IT)
2/2012 – 6/2017
Tätigkeitsbeschreibung
Mobile Allergen Exposure Chamber
- Project management
- Design of a mobile exposure chamber for allergen exposure tests in clinical trials
- Design of a patented particle disperse unit
- Design of a patented device to blister particles
- Design of a new particle counting microscope and associated software
- Create and present various Posters at EAACI Conference Barcelona, Vienna
- Co-author various publications
Klinische Forschung, Bildverarbeitung, Mechanische Systeme
1/2012 – 4/2017
Tätigkeitsbeschreibung
Personal Aeroallergen Sampler
- Design of a mobile device to track exposure to respiratory allergens
- Cooperation with Allergy-Center of Charité and University of applied science Mainz
- Design of housing and mechanical components
- Won innovation price of Rhineland-Palatinate in 02/2014
Klinische Forschung, Mechanische Systeme
Zertifikate
TUEV Sued
Ausbildung
University of Applied Sciences Mainz
Mainz
Über mich
With a robust career spanning over two decades, I bring a wealth of experience in leading operations, driving technological innovation, and managing product development across various industries, including medical technology and life sciences.
Key Expertise:
- Regulatory Compliance: In-depth knowledge of regulatory requirements, particularly in the medical device, aerospace and railway sectors, with hands-on experience in leading risk and safety management strategies for product approvals.
- Research & Development (R&D): Extensive experience in establishing and leading R&D departments, fostering innovation, and overseeing the development of cutting-edge products from concept to market launch.
- Product Development: Expertise in managing the entire product lifecycle, including design, development, and commercialization, ensuring products meet market needs and regulatory standards.
- Operations Management: Skilled in optimizing operational processes, enhancing efficiency, and managing large-scale projects with budgets exceeding $100 million annually.
- Strategic Leadership: Proven track record in formulating and executing corporate strategies that align with business objectives and drive growth.
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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