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Title
Text copied to clipboard!Medical Device Engineer
Description
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We are looking for a Medical Device Engineer to join our dynamic team dedicated to advancing healthcare technology. As a Medical Device Engineer, you will play a critical role in designing, developing, testing, and improving medical devices that enhance patient care and safety. You will collaborate with cross-functional teams including clinicians, regulatory experts, and manufacturing specialists to ensure that products meet both user needs and regulatory standards. Your responsibilities will include conducting research to identify user requirements, creating detailed design specifications, prototyping, and overseeing the testing and validation of devices. You will also be involved in troubleshooting and refining existing products, ensuring compliance with industry regulations such as FDA and ISO standards, and preparing technical documentation for regulatory submissions. The ideal candidate will have a strong background in biomedical engineering, mechanical engineering, or a related field, with experience in product development and a passion for innovation in healthcare. Excellent problem-solving skills, attention to detail, and the ability to work effectively in a team environment are essential. If you are committed to making a positive impact on patient outcomes and thrive in a fast-paced, challenging environment, we encourage you to apply for this rewarding opportunity.
Responsibilities
Text copied to clipboard!- Design and develop new medical devices and equipment
- Conduct research to determine user needs and requirements
- Create detailed design specifications and technical drawings
- Prototype, test, and validate medical devices
- Ensure compliance with regulatory standards (FDA, ISO, etc.)
- Collaborate with cross-functional teams including clinicians and manufacturers
- Troubleshoot and improve existing products
- Prepare technical documentation for regulatory submissions
- Participate in risk assessments and design reviews
- Support manufacturing and quality assurance processes
Requirements
Text copied to clipboard!- Bachelor’s degree in biomedical engineering, mechanical engineering, or related field
- Experience in medical device design and development
- Knowledge of regulatory standards (FDA, ISO 13485, etc.)
- Strong problem-solving and analytical skills
- Proficiency with CAD software and engineering tools
- Excellent communication and teamwork abilities
- Attention to detail and organizational skills
- Ability to manage multiple projects simultaneously
- Experience with prototyping and testing methodologies
- Understanding of manufacturing processes and materials
Potential interview questions
Text copied to clipboard!- What experience do you have in medical device development?
- Can you describe a challenging engineering problem you solved?
- How do you ensure compliance with regulatory standards?
- What CAD software are you proficient in?
- Describe your experience with prototyping and testing.
- How do you approach cross-functional collaboration?
- What motivates you to work in the medical device industry?
- How do you handle tight deadlines and multiple projects?
- Have you participated in regulatory submissions before?
- What is your experience with risk assessment in product design?
