Job Summary
The role involves the design, prototyping, testing, and improvement of medical devices and their components, guiding projects from initial concepts to market release. Key tasks include developing testing protocols, ensuring thorough verification and validation, maintaining necessary design and quality records, and supporting compliance with regulatory standards for product safety. The position also entails coordinating pilot production efforts across various functions and offering technical assistance for products and addressing any complaints.
Responsibilities
- Design and prototype medical devices from initial concepts to commercialization.
- Develop test methodologies along with conducting validation and verification processes.
- Maintain design and quality documentation throughout the product lifecycle.
- Ensure compliance with regulatory requirements and uphold product safety standards.
- Facilitate cross-functional coordination for pilot production initiatives.
- Provide technical support during product development and for complaint resolution.
Qualifications
- Bachelor’s degree in Engineering, with a preference for Mechanical or Biomedical Engineering.
- A minimum of five years of engineering experience within the medical device sector.
- Proficiency in CAD software.
- Strong problem-solving abilities and proficiency in technical documentation.
- Capability to work collaboratively across multiple functions.
- Experience with catheter-based products is preferred.
- Willingness to travel up to 15% as required by the role.
