Jan-Willem Puttenstein
Project Manager Product Development at Polyganics BV- Claim this Profile
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Bio
Experience
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Regenity Biosciences (Formerly Polyganics)
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Project Manager Product Development
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Aug 2021 - Present
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Gulf Christian Services
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Kikori, Gulf Province, Papua New Guinea
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Project Manager
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Jun 2019 - May 2021
Based in the dense and remote jungle, Gulf Christian Services (GCS) serves over 50,000 people in the Gulf Province of Papua New Guinea (PNG). GCS is a faith-based organization that provides medical care, training, leadership and community development to the local communities. GCS has two hospitals, a training school, primary school, church and shop divided over two locations in the heart of the province. My role as a project manager is to coordinate a team of local semi-professionals to renovate and upgrade the facilities on our hospital premises. My job involves resource management, donor acquisition & accountability, communication with stakeholders, procurement & logistics management and quality control. In this environment where everything is scarce, it is key to optimize the resource utilization as much as possible. Show less
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PureIMS
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Netherlands
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Biomedical Engineer
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Jan 2017 - May 2019
Pure Inhalation Medication Systems (PureIMS) is a clinical-stage biopharmaceutical company specialized in development, manufacturing and commercialization of inhaled drugs for patients. PureIMS closely collaborates with the Department of Pharmaceutical Technology and Biopharmacy (University of Groningen). Specific focus areas of my job were: - Product and process development of drug-device combinations - Implementation of new technologies and equipment in the production facility - Management, validation and maintenance of the production facility and production lines - Preparation and maintenance of product dossiers for the filing of products at EMEA - Implementation and maintenance of a QMS based on the ISO 9001:2015 and GMP standards - Registration and maintenance of the manufacturer’s registration status - Management of the construction of a class D clean room Show less
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IMDS
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Sep 2014 - Jan 2017
The R&D department of IMDS B.V. focuses on the development and market introduction of medical devices and its required CE registration. As New Product Developer in a multidisciplinary team within an ISO 13485 certified company, I was responsible for:- Product and process development from scratch of several products for complex coronary interventions- Technical File documentation for CE Marking to demonstrate compliance with European requirements- New or improved product transfers to the operations department- Technology transfer and implementation and validation of new production processes Show less
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Feb 2014 - Aug 2014
I wrote my master's thesis 'Optimization of a balloon catheter design and matrix for a PTCA device platform' at the ISO 13485 certified company IMDS in Roden. This project involved the development and in-house manufacturing of a balloon catheter design. The purpose of this master’s project was to optimize the balloon component and the geometry matrix for the PTCA device platform. Insights in the balloon design and manufacturing process were gathered by doing literature research and several Design of Experiments with varying different parameter settings along the manufacturing process. A design algorithm could be defined and confirmed to a reliable level in which all the requirements were met.During the employment directly after the internship, I worked on the design and optimization of a microcatheter system for interventional cardiology. Show less
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Axios dragers
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Groningen
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Pallbearer
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Dec 2011 - Dec 2015
Pallbearer and foreman at funeral services Pallbearer and foreman at funeral services
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Education
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Rijksuniversiteit Groningen
Master of Science (MSc), Biomedical Engineering -
Rijksuniversiteit Groningen
Bachelor of Science (BSc), Life Science & Technology -
Carolus Clusius College
vwo, Natuur & Gezondheid