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Title
Text copied to clipboard!Medical Device Engineer
Description
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We are looking for a highly skilled and motivated Medical Device Engineer to join our dynamic team. The ideal candidate will have a strong background in biomedical engineering, mechanical engineering, or a related field, with a passion for developing innovative medical devices that enhance patient care and improve healthcare outcomes. As a Medical Device Engineer, you will be responsible for the design, development, testing, and implementation of medical devices, ensuring they meet regulatory standards and are safe and effective for use. You will work closely with cross-functional teams, including clinicians, researchers, and regulatory experts, to bring new medical devices from concept to market. Your role will involve conducting research, creating detailed design specifications, prototyping, and performing rigorous testing to ensure the devices meet all necessary requirements. Additionally, you will be involved in the preparation of technical documentation, regulatory submissions, and post-market surveillance activities. The successful candidate will have excellent problem-solving skills, a keen eye for detail, and the ability to work effectively in a fast-paced, collaborative environment. If you are passionate about making a difference in the healthcare industry and have the technical expertise to develop cutting-edge medical devices, we would love to hear from you.
Responsibilities
Text copied to clipboard!- Design and develop innovative medical devices.
- Conduct research to identify user needs and technical requirements.
- Create detailed design specifications and technical drawings.
- Develop prototypes and conduct testing to ensure device functionality and safety.
- Collaborate with cross-functional teams, including clinicians and researchers.
- Ensure compliance with regulatory standards and guidelines.
- Prepare technical documentation and regulatory submissions.
- Perform risk assessments and develop mitigation strategies.
- Conduct failure analysis and implement corrective actions.
- Participate in design reviews and provide technical feedback.
- Support manufacturing and production processes.
- Conduct post-market surveillance and gather user feedback.
- Stay updated with industry trends and advancements.
- Provide technical support and training to end-users.
- Manage project timelines and deliverables.
- Ensure quality control and continuous improvement.
- Develop and maintain relationships with key stakeholders.
- Participate in industry conferences and workshops.
- Contribute to the development of company policies and procedures.
- Mentor and train junior engineers.
Requirements
Text copied to clipboard!- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field.
- Master's degree preferred.
- Proven experience in medical device design and development.
- Strong knowledge of regulatory standards (e.g., FDA, ISO).
- Proficiency in CAD software and other design tools.
- Experience with prototyping and testing methodologies.
- Excellent problem-solving and analytical skills.
- Strong attention to detail and accuracy.
- Ability to work effectively in a team environment.
- Excellent communication and interpersonal skills.
- Project management skills and ability to meet deadlines.
- Knowledge of manufacturing processes and materials.
- Understanding of human factors and usability engineering.
- Experience with risk management and failure analysis.
- Ability to prepare and review technical documentation.
- Familiarity with quality control and assurance processes.
- Willingness to stay updated with industry trends.
- Ability to travel as needed.
- Strong organizational and multitasking skills.
- Commitment to continuous learning and professional development.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with medical device design and development?
- How do you ensure compliance with regulatory standards in your projects?
- What CAD software and design tools are you proficient in?
- Can you provide an example of a challenging problem you solved in a previous project?
- How do you approach risk management and failure analysis?
- Describe a time when you had to collaborate with a cross-functional team.
- How do you stay updated with industry trends and advancements?
- What is your experience with prototyping and testing methodologies?
- How do you handle tight project deadlines and manage multiple tasks?
- Can you discuss a project where you had to prepare technical documentation and regulatory submissions?
- What strategies do you use to ensure quality control and continuous improvement?
- How do you gather and incorporate user feedback into your designs?
- Describe your experience with manufacturing processes and materials.
- How do you approach human factors and usability engineering in your designs?
- What steps do you take to mentor and train junior engineers?
- Can you discuss a time when you had to provide technical support to end-users?
- How do you manage project timelines and deliverables?
- What is your experience with post-market surveillance activities?
- How do you develop and maintain relationships with key stakeholders?
- What motivates you to work in the medical device industry?
