Position Summary:
We are a cutting-edge medical device company dedicated to revolutionizing healthcare through innovative technologies. Our team is committed to developing state-of-the-art devices that enhance patient care and improve clinical outcomes. As part of our continuous growth, we are seeking a talented engineer to join our dynamic team. As an Engineer specializing in medical devices, you will play a crucial role in the design, development, and testing of our groundbreaking medical products.
Key Responsibilities:
Design and Development: Collaborate with cross-functional teams to conceptualize, design, and develop new medical devices from initial concept to commercialization.
Prototyping: Utilize advanced CAD software and rapid prototyping techniques to create prototypes for feasibility testing and product validation.
Regulatory Compliance: Ensure all designs meet regulatory standards and guidelines for medical devices, such as FDA regulations and ISO standards.
Testing and Validation: Develop and execute comprehensive testing protocols to validate device performance, reliability, and safety.
Documentation: Generate detailed design documentation, including specifications, drawings, test plans, and reports, to support regulatory submissions and manufacturing processes.
Collaboration: Work closely with manufacturing, quality assurance, and regulatory affairs teams to support product manufacturing, validation, and regulatory submissions.
Continuous Improvement: Identify areas for improvement in design processes, tools, and methodologies to enhance product quality and efficiency.
Qualifications:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field; Master's degree preferred.
Minimum of 5 years of experience in the design and development of medical devices or closely related industries.
Proficiency in CAD software (e.g., SolidWorks, Pro/ENGINEER) for 3D modeling and design.
Strong understanding of medical device regulations, including FDA guidelines and ISO standards.
Experience with design verification and validation testing methodologies, including statistical analysis.
Excellent problem-solving skills and the ability to work effectively in a cross-functional team environment.
Effective communication skills, with the ability to clearly articulate technical concepts to diverse stakeholders.
What We Offer:
Competitive salary and a diverse benefits package customised to your preferences and needs.
Friendly and highly professional working atmosphere in an international context.
Learning environment, support for proper onboarding.
A dynamic and professional working environment with multiple development opportunities
Work Equipment: MacBook Pro and Iphone if needed.
26 days Holiday
Work hybrid - 4 days at the office and 1 day remote
