Job Overview:
We are seeking a skilled and innovative Senior Mechanical Design Engineer to join a dynamic team, focused on the design and development of cutting-edge tracheostomy products. This role involves driving the product development process from early concept stages through to commercialization. The ideal candidate will have a strong background in plastics engineering, material science, and process development, particularly in tooling and molding. Experience in medical device development, risk management, and human factors engineering will be highly advantageous.
Key Responsibilities:
* Lead the mechanical design and development of tracheostomy products, ensuring innovative and functional solutions from concept to final product launch.
* Collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to ensure product designs meet all technical, regulatory, and usability requirements.
* Apply expertise in plastics engineering and material science to select appropriate materials and develop efficient manufacturing processes, with a focus on tooling and molding.
* Conduct risk management activities, including hazard analysis, FMEA, and design validation, to ensure the safety and reliability of the product.
* Integrate human factors engineering principles into product design to enhance usability, patient safety, and user experience.
* Develop and maintain detailed engineering documentation, including 3D models, technical drawings, specifications, and test plans.
* Support the product testing and validation process, including prototyping, simulations, and verification activities.
* Stay up-to-date with industry trends, advancements in medical device design, and relevant regulatory standards to inform design decisions and maintain competitive advantage.
Qualifications:
* Bachelor's degree in Mechanical Engineering, Plastics Engineering, or a related field; advanced degree preferred.
* Proven experience in mechanical design, with a focus on medical devices
* Strong understanding of plastics engineering, material science, and process development for tooling and molding.
* Familiarity with human factors engineering and its application in medical device design.
* Proficiency in CAD software (e.g., SolidWorks, Creo) and other relevant engineering tools.
* Excellent problem-solving skills, with the ability to work independently and collaboratively in a team environment.
* Strong communication skills, both written and verbal, with the ability to convey complex technical information to a diverse audience.