Technical Director
2 weeks ago
About the Company:
An innovative medical device manufacturer based in Neuchâtel is expanding their senior leadership team. They are looking for a Technical Director to join their expanding team, requiring 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 while 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 tasks 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.
- 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.
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