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4 months ago
An innovative medical device manufacture based in Neuchâtel is expanding their senior leadership team. They are looking for a Technical Director to join their expanding team, they need an experienced individual to assist in the further development of their non-invasive therapies. The role encompasses all aspects from R&D, quality, regulatory affairs whilst working cross-functionally with all departments.
Responsibilities:
* Assure all product quality according to the relevant valid directives are placed on the market in a timely manner and in a most cost efficient way
* Lead product and production equipment transformation, modification, adaptation and development to constantly improve efficiency and quality
* Oversee the design and introduction of production tools, CAD design tasks
* Plan, manage and follow-up business objectives, QMS measures and any other task deriving from Management review report
* Responsible for product registration / certification / approval, particularly with regard to US (510K, PMA) and Canada (MDL)
* Ensure the conformity of products with legal standards and requirements (e.g. EU, USA, China markets)
* Handle and negotiate contracts with external suppliers and other partners
Requirements:
* Bachelor's degree in a relevant field
* 10+ years experience within the medical device industry
* Proven experience in quality management, regulatory affairs, research and development and medical device manufacturing.
* Familiarity with ISO 13485 and other relevant quality standards.
* Strong leadership, communication, and problem-solving skills.
* Ability to balance strategic thinking with hands-on execution.
If interested please reach out with an updated version of your resume. #J-18808-Ljbffr