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Medical Device Development Leader
Amaris is an independent and international Consulting Group specialized in Management and Technologies.
Amaris operates in over 45 countries delivering services in Business & Management Consulting, IT/Information Systems, Telecommunications & Networking, Engineering, Pharmaceutical & Biotechnology.
Since 2007, the company has grown exponentially and is committed to building lasting relationships with its clients, delivering innovative solutions from project inception to execution.
• 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
o Monitor work progress according to plan
o Monitor, support and challenge technical development as well as test and verification work
o Monitor development and implementation of manufacturing processes
o Coordinate and monitor technical documentation
• Compile Design Control documentation remediation and contributing to a high quality Design History file
An ideal candidate would have a relevant degree in engineering and at least 8 years of experience in a similar area, including:
• Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive);
• DHF compilation;
• Experience in pharmaceutical companies
• Experience in leading packaging/device/combination product projects
• Experience in remediation projects;
o Product design/Design for manufacture
• Experience of managing external suppliers;
• Good communication and conflict solving skills;
• Good technical knowledge in primary containers, e.g. syringes and cartridges
• General understanding of Human Factors Engineering and Risk management
• Good understanding of clinic studies processes and requirements.
• Good understanding of pharmaceutical development in general.
Master degree in Science/Engineering or Mechanical Engineering or University level Engineering education.