Description
We are seeking an Engineer-MDD with 3-5 years of experience to join our team. The ideal candidate will have a strong understanding of product development processes, design control, and regulatory requirements related to medical devices. The role requires the ability to work in a fast-paced environment, excellent communication skills, and a strong desire to learn and grow.
Responsibilities
- Design and develop medical devices in accordance with regulatory requirements and design controls
- Conduct risk assessments and develop risk management plans
- Create and maintain design documentation, including design input and output documentation, verification and validation plans, and design reviews
- Collaborate with cross-functional teams to ensure product development milestones are met and products are launched on time
- Stay up-to-date with industry trends and regulatory changes related to medical devices
Skills and Qualifications
- Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field
- 3-5 years of experience in medical device design and development
- Strong understanding of design controls, risk management, and regulatory requirements (FDA, ISO, etc.)
- Proficiency in CAD software (e.g. SolidWorks)
- Experience with product development processes, including design inputs, outputs, verification, and validation
- Excellent communication and interpersonal skills
- Ability to work in a fast-paced environment and manage multiple projects simultaneously
- Experience with electromechanical systems and software development is a plus
