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Title
Text copied to clipboard!Medical Device Engineer
Description
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We are looking for a dedicated and innovative Medical Device Engineer to join our dynamic team. The ideal candidate will be responsible for designing, developing, testing, and improving medical devices and equipment that enhance patient care and medical procedures. You will collaborate closely with multidisciplinary teams, including healthcare professionals, regulatory specialists, and manufacturing experts, to ensure that all products meet stringent quality standards and regulatory requirements.
As a Medical Device Engineer, you will play a crucial role in the entire lifecycle of medical devices, from initial concept and design through prototyping, testing, validation, and final production. You will utilize your technical expertise and creativity to solve complex engineering challenges, ensuring that devices are safe, effective, and reliable. Your responsibilities will include conducting research to identify user needs, developing detailed design specifications, creating prototypes, and performing rigorous testing to validate device performance and safety.
You will also be responsible for ensuring compliance with regulatory standards such as FDA, ISO, and other international guidelines. This includes preparing documentation for regulatory submissions, maintaining accurate records of design processes, and participating in audits and inspections. Additionally, you will provide technical support to manufacturing teams, troubleshoot issues during production, and implement continuous improvement initiatives to enhance product quality and efficiency.
The successful candidate will possess strong analytical and problem-solving skills, excellent communication abilities, and a passion for innovation in healthcare technology. You should be comfortable working independently as well as collaboratively within a team environment. Attention to detail, organizational skills, and the ability to manage multiple projects simultaneously are essential for success in this role.
We offer a stimulating work environment where you will have the opportunity to contribute to meaningful projects that directly impact patient care and medical outcomes. Our organization values professional growth and provides ongoing training and development opportunities to help you advance your career. If you are passionate about engineering excellence and committed to improving healthcare through innovative medical device solutions, we encourage you to apply and become part of our dedicated team.
Responsibilities
Text copied to clipboard!- Design and develop innovative medical devices and equipment.
- Conduct research to identify user needs and translate them into design specifications.
- Create prototypes and perform rigorous testing to validate device performance and safety.
- Ensure compliance with regulatory standards such as FDA, ISO, and international guidelines.
- Prepare documentation for regulatory submissions and maintain accurate design records.
- Collaborate with multidisciplinary teams including healthcare professionals and manufacturing experts.
- Provide technical support to manufacturing teams and troubleshoot production issues.
- Implement continuous improvement initiatives to enhance product quality and efficiency.
Requirements
Text copied to clipboard!- Bachelor's degree or higher in Biomedical Engineering, Mechanical Engineering, or related field.
- Minimum of 3 years of experience in medical device design and development.
- Strong knowledge of regulatory standards including FDA, ISO 13485, and CE marking.
- Proficiency in CAD software such as SolidWorks, AutoCAD, or similar tools.
- Experience with prototyping, testing, and validation of medical devices.
- Excellent analytical, problem-solving, and communication skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Strong attention to detail and commitment to quality and safety standards.
Potential interview questions
Text copied to clipboard!- Can you describe your experience with designing and developing medical devices?
- How do you ensure compliance with regulatory standards during the design process?
- What CAD software are you proficient in, and how have you used it in previous projects?
- Can you provide an example of a challenging engineering problem you faced and how you solved it?
- How do you approach collaboration with multidisciplinary teams during device development?
