Key Responsibilities:

Design and develop medical devices from concept to commercialization, ensuring compliance with regulatory requirements.
Conduct research and analysis to identify potential solutions and make recommendations for product improvements.
Collaborate with cross-functional teams including product managers, clinicians, and regulatory specialists to develop and implement product specifications.
Create and maintain technical documentation, including design specifications, test protocols, and reports.
Perform risk assessments and mitigate potential risks associated with product design and development.
Coordinate and manage external vendors and suppliers to ensure timely delivery of quality components.
Conduct design verification and validation activities, including testing and data analysis.
Participate in design reviews and provide technical support to resolve any issues.
Stay current with industry trends, advancements, and changes in regulations related to medical device development.
Continuously improve processes and procedures to increase efficiency and ensure compliance with quality standards.

Qualifications:

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
Minimum of 5 years of experience in medical device design and development.
Strong understanding of engineering principles, including design control, risk management, and verification and validation.
In-depth knowledge of medical device regulations and standards, such as FDA regulations, ISO 13485, and MDD/MDR.
Experience with CAD software and proficiency in creating technical drawings.
Excellent problem-solving skills and attention to detail.
Effective communication and collaboration skills.
Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.

If you have a passion for developing innovative medical devices and ensuring their safety and efficacy, we encourage you to apply for this exciting opportunity.

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