Join our team of passionate and driven individuals dedicated to making a positive impact in the healthcare industry.
Position: Medical Devices Engineer
Location: Kecskemét, Hungary
Overview: As a Medical Devices Engineer, you will play a critical role in the design, development, and testing of medical devices that will improve the lives of patients. You will work closely with a team of engineers, designers, and healthcare professionals to create innovative solutions that meet the highest standards of quality and safety. Your work will have a direct impact on the healthcare industry, as well as the lives of countless individuals.
Key Responsibilities:
- Design and develop medical devices from concept to commercialization, ensuring all products meet regulatory and quality standards
- Collaborate with cross-functional teams to identify user needs, develop product requirements, and define project timelines
- Conduct research and stay up-to-date on industry trends, regulations, and best practices to inform design decisions
- Utilize engineering principles, such as design for manufacturability, to optimize product performance and reduce production costs
- Create and maintain detailed design documentation, including specifications, drawings, and test plans
- Perform risk assessments and implement risk mitigation strategies throughout the product development process
- Oversee prototype fabrication and testing, and provide technical support to ensure successful completion of projects
- Participate in design reviews and provide constructive feedback to improve product design and functionality
- Support regulatory submissions and work with regulatory agencies to obtain necessary approvals for product launch
- Collaborate with suppliers to ensure the timely delivery of high-quality components and materials
- Troubleshoot and resolve technical issues during product development and post-market phases
- Continuously improve product design and development processes to ensure efficiency and compliance with regulatory requirements
Qualifications:
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field
- Minimum of 3 years of experience in medical device design and development
- Strong knowledge of medical device regulations, including FDA and ISO standards
- Proficiency in CAD software, such as SolidWorks, for design and modeling
- Experience with prototyping and testing techniques, such as 3D printing and FEA analysis
- Excellent problem-solving and analytical skills, with an attention to detail
- Ability to work independently and collaboratively in a fast-paced, dynamic environment
- Strong communication and interpersonal skills, with the ability to effectively communicate technical information to non-technical stakeholders
- Willingness to travel as needed for project-related activities
Apply now to be a part of our exciting and rewarding journey to improve the lives of patients through innovative medical devices.