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Medical Device Development Project Leader
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Design
Projektbeschreibung
For one of our clients, one of the leading pharmaceutical companies, Harvey Nash is looking for a Medical Device Development Project Leader. This is a contract role in Basel.
Professional Experience:
An ideal candidate would have at least 8 years of experience in leading device development of parenteral delivery systems, eg drug/device combination products with main focus on devices for parenteral administration.
Requirement for the role are:
* Experience in leading packaging/device/combination product projects;
* Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
* Experience in Product design and Design for manufacture;
* Experience of managing external suppliers;
* Good communication and conflict solving skills;
* Good technical knowledge of primary containers development
* General understanding of Human Factors Engineering and Risk management
* Good understanding of clinic studies processes and requirements.
* Good understanding of pharmaceutical development in general.
* Experience in Opthalmic application device development
Main Tasks:
* Deliver project according to plan at project milestones;
* Plan and lead technical activities;
* Manage technical development activities in collaboration with internal stakeholders as well as in the projects teams;
* Lead the collaboration with external development partners;
* Monitor work progress according to plan;
* Monitor, support and challenge technical development as well as test and verification work;
* Monitor development and implementation of manufacturing processes;
* Coordinate and monitor technical documentation.
Other Tasks:
* Compile Design Control documentation remediation and contributing to a high quality Design History file.
Education:
Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education.
Language:
Excellent skills in English language are required.
Should you be interested, please, contact me at your earliest convenience.
E:
(see below)
Professional Experience:
An ideal candidate would have at least 8 years of experience in leading device development of parenteral delivery systems, eg drug/device combination products with main focus on devices for parenteral administration.
Requirement for the role are:
* Experience in leading packaging/device/combination product projects;
* Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
* Experience in Product design and Design for manufacture;
* Experience of managing external suppliers;
* Good communication and conflict solving skills;
* Good technical knowledge of primary containers development
* General understanding of Human Factors Engineering and Risk management
* Good understanding of clinic studies processes and requirements.
* Good understanding of pharmaceutical development in general.
* Experience in Opthalmic application device development
Main Tasks:
* Deliver project according to plan at project milestones;
* Plan and lead technical activities;
* Manage technical development activities in collaboration with internal stakeholders as well as in the projects teams;
* Lead the collaboration with external development partners;
* Monitor work progress according to plan;
* Monitor, support and challenge technical development as well as test and verification work;
* Monitor development and implementation of manufacturing processes;
* Coordinate and monitor technical documentation.
Other Tasks:
* Compile Design Control documentation remediation and contributing to a high quality Design History file.
Education:
Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education.
Language:
Excellent skills in English language are required.
Should you be interested, please, contact me at your earliest convenience.
E:
(see below)
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Medien/Design, Ingenieurwesen/Technik