Biomedical Engineer (Medical Device Industry)

Job Title : Biomedical Engineer (Medical Device Industry)

Location : United States (Location details specific to the role)

Duration : 12 months (Contract on W2)

Job Description :

We are looking for a highly motivated Biomedical Engineer to join our team within the medical device industry . In this role, you will be involved in the design, development, and testing of medical devices, ensuring that they meet both regulatory standards and functional requirements. You will work closely with other engineering disciplines and collaborate with cross-functional teams to bring innovative, safe, and effective medical devices to market. This is an excellent opportunity to be a part of a growing industry and make a tangible impact on patient care.

Key Responsibilities :

• Design and develop medical devices, focusing on functionality, safety, and usability, while ensuring compliance with industry standards.
• Conduct feasibility studies, design evaluations, and technical assessments to ensure that device concepts meet clinical and regulatory requirements.
• Develop and execute test plans for device validation, including performance testing , biocompatibility testing , and regulatory testing (e.g., FDA guidelines, ISO 13485).
• Perform design calculations, simulations, and analysis to evaluate device performance, reliability, and safety.
• Collaborate with cross-functional teams (manufacturing, regulatory affairs, quality assurance, and clinical) to ensure that designs meet regulatory standards (FDA, ISO 13485).
• Support design transfer activities, ensuring that devices can be efficiently manufactured, tested, and assembled according to specifications.
• Review and update technical documentation including Design History Files (DHF) , Risk Management Files (RMF) , and Design Control processes.
• Participate in design reviews to ensure designs align with customer needs, functional requirements, and regulatory standards.
• Assist in the development of medical device labeling , packaging designs, and instructions for use (IFU) in compliance with regulatory guidelines.
• Provide technical expertise and support during product development, troubleshooting, and product life cycle management.
• Contribute to the preparation and submission of regulatory documents for product approvals (e.g., 510(k), PMA).

Required Qualifications :

Preferred Qualifications :