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Title

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Medical Device Engineer

Description

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We are looking for a highly skilled and innovative Medical Device Engineer to join our team. In this role, you will be responsible for designing, developing, and testing medical devices that improve patient care and healthcare outcomes. You will work closely with cross-functional teams, including researchers, clinicians, and regulatory experts, to ensure that the devices meet both technical and regulatory standards. Your expertise will contribute to the creation of cutting-edge medical technologies that address critical healthcare challenges. As a Medical Device Engineer, you will be involved in the entire product lifecycle, from concept development to manufacturing and post-market support. You will use your engineering knowledge to create devices that are safe, effective, and user-friendly. This role requires a strong understanding of engineering principles, materials science, and medical regulations. You will also need excellent problem-solving skills and the ability to work collaboratively in a fast-paced environment. Your work will have a direct impact on improving the quality of life for patients and advancing the field of medical technology. If you are passionate about innovation and have a strong background in engineering, we encourage you to apply for this exciting opportunity.

Responsibilities

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  • Design and develop medical devices from concept to production.
  • Conduct feasibility studies and risk assessments for new designs.
  • Collaborate with cross-functional teams to meet project goals.
  • Ensure compliance with medical device regulations and standards.
  • Perform testing and validation of prototypes and final products.
  • Document design processes and maintain technical files.
  • Support manufacturing teams during production scale-up.
  • Stay updated on industry trends and emerging technologies.

Requirements

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  • Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field.
  • Proven experience in medical device design and development.
  • Strong knowledge of medical device regulations (e.g., FDA, ISO 13485).
  • Proficiency in CAD software and engineering tools.
  • Excellent problem-solving and analytical skills.
  • Strong communication and teamwork abilities.
  • Attention to detail and commitment to quality.
  • Experience with materials science and biocompatibility is a plus.

Potential interview questions

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  • Can you describe your experience with medical device design and development?
  • How do you ensure compliance with medical device regulations?
  • What engineering tools and software are you proficient in?
  • Can you provide an example of a challenging project you worked on?
  • How do you approach risk assessment in medical device development?
  • What steps do you take to ensure product quality and safety?
  • How do you stay updated on industry trends and advancements?
  • What experience do you have with cross-functional team collaboration?