NPD & NPI Lead Engineer, Medtech
|Contact Name:||Larry O’Leary|
Our client, a Medtech company based in Dublin, now seek a NPD & NPI Lead Engineer to provide technical engineering leadership to manufacturing environment, delivering processes into production to meet objectives in NPI, product commercialization and supplier projects.
The successful candidate will work as a part of a cross functional leading NPD & NPI through design development, verification, clinical trials, validation and regulatory approval.
The ideal candidate will be an experienced medical devices professional, with strong problem-solving abilities in the resolution of complex technical issues. This role will suit a high functioning individual, who enjoys working in a dynamic innovative development environment.
Responsibilities of NPD & NPI Lead Engineer, Medtech:
Lead on all manufacturing activities from cleanroom management, supplier qualification, internal equipment and process controls, packaging and sterilization.
Planning, implementing and co-ordination of manufacturing pertaining to NPI and commercialisation.
Develop and update documentation relating to equipment or processes to manufacture, in line with Regulatory standards.
Development of manufacturing processes in conjunction with R&D.
Sourcing and implementing tooling, equipment and technologies to manufacture.
Process development and characterisation including PFMEA.
Lead cross functional teams to assess and qualify suppliers to ensure a robust supply chain.
Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
Requirements for NPD & NPI Lead Engineer, Medtech:
Bachelors or Masters Degree in Engineering or related disciplines
8+ years medical device experience in New Product Development, New product Introduction, Manufacturing and / or Project Engineering.
Experienced project manager, with proven skills in managerial, project and technical aspects.
Broad knowledge of materials and processes applicable to medical device industry is desirable.
Proven knowledge of FDA, GMP, QSR and ISO 13485 requirements.
Experience of preparing technical documentation
Excellent communication, organisational and time management skills
Flexibility to travel to vendor sites to support service and project activities.
Please contact Larry on +353 1-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie
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