Job Description:
We are seeking a highly skilled and experienced professional to join our team in the development of complex medical devices.
The ideal candidate will have a strong interest in the development of electronic, software, and mechanical medical devices and will be responsible for defining and ensuring compliance with quality requirements for drug delivery systems and medical devices in development projects.
The successful candidate will ensure the conformity of our products and product documentation over the entire product life cycle, focusing on development and industrialization, including Design Control.
Key Responsibilities:
* Ensuring compliance with quality requirements for drug delivery systems and medical devices
* Collaborating in risk analyses
* Creating/ approving documents for design verification/design validation
* Designing test plans/test setups/design of experiment
* Reviewing/approving changes to product design and manufacturing processes
* Contacting customers and suppliers regarding product quality
* Collaborating in equipment qualification/process validation and evaluation of external production partners
Requirements:
The successful candidate will possess:
* A completed technical or scientific education or equivalent
* Several years of experience in working in the field of medical technology products, pharmaceuticals, and/or in-vitro diagnostics
* Practical experience in risk management methods for medical devices
* Knowledge in interpreting and implementing regulatory requirements for medical devices (MDR, EN ISO 14971, 21 CFR 820, EN 13485)
* A structured and result-oriented way of working
* Ability to prioritize and make decisions
* Solution-oriented and communicative personality
* Confident communication skills across all hierarchical levels, internally and with customers
What We Offer:
We offer a challenging and dynamic work environment, opportunities for growth and development, and a competitive compensation package. If you are a motivated and experienced professional looking to take your career to the next level, please submit your application.