We are seeking a skilled and experienced Biomedical Engineer to join our dynamic team. The ideal candidate will have a strong background in verification and validation (V&V) testing of medical devices, ensuring compliance with industry standards. Knowledge of point-of-care (POC) diagnostics is highly desirable. The role also requires proficiency in wet lab techniques and a thorough understanding of the electronics and mechanical assemblies of medical instruments.
Key Responsibilities:
- Conduct verification and validation testing for medical devices, ensuring compliance with relevant standards and regulations (e.g., FDA, ISO 13485, IEC 60601).
- Develop and execute test protocols, analyze test results, and document findings.
- Perform risk analysis and create risk management documentation.
- Maintain up-to-date knowledge of POC diagnostics technologies and their applications.
- Utilize wet lab skills for device testing and validation.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Regulatory Affairs, to ensure product quality and compliance.
- Understand and work with the electronics and mechanical assemblies of instruments to troubleshoot and resolve issues.
- Prepare detailed technical reports and presentations for internal and external stakeholders.
Qualifications:
- Bachelor's or Master's degree in Biomedical Engineering or a related field.
- Minimum of 3 years of experience in verification and validation testing of medical devices.
- Strong understanding of regulatory requirements and standards (e.g., FDA, ISO 13485, IEC 60601).
- Understanding of PID (Proportional, Integral, Derivative) gains to optimize system performance and stability.
- Proficiency in wet lab techniques and procedures.
- Solid understanding of electronics and mechanical assemblies of medical instruments.
- Excellent analytical and problem-solving skills.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a multidisciplinary team.
- Detail-oriented with a commitment to quality and accuracy.
Preferred Qualifications:
- Experience with software validation and verification.
- Knowledge of POC diagnostics and their applications.
- Familiarity with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP).
- Certification in relevant quality or regulatory areas.
