Innovative, fast-growing start-up revolutionising pediatric care with a unique Class III medical device, empowering young patients to live a better life.
You will contribute to:
1. 3D modeling
2. Drafting
3. Dimensioning
4. Tolerance calculations
You will:
1. Implement product specifications and requirements.
2. Drive cost efficiency through strategic material research and in-depth analysis.
3. Lead and support process validation activities, including IQ, OQ, and PQ, ensuring compliance with all regulatory requirements and industry standards.
4. Manage product development risks and oversee the entire documentation cycle.
5. Foster strong partnerships with suppliers and contract manufacturers to support product development and industrialisation.
Challenging and fast-growing environment with career opportunities.
Minimum Requirements:
1. Bachelor's or Master's degree in Mechanical, Biomedical, Materials Science, or a related technical field.
2. At least 4 years of experience in product engineering development within the medical device industry, preferably with Class III products.
3. Proficiency in CAD: 2D and 3D.
4. Knowledge of the medical device industry regulations (FDA, MDR, ISO 13485 and ISO 14971).
5. Interest in working in agile environments, like startups.
#J-18808-Ljbffr