We are an engineering recruitment firm in search of a Biomedical Engineer for our client. Our client is at the forefront of medical device innovation, specializing in the development of cutting-edge diagnostic instruments and surgical tools that improve patient outcomes and enhance healthcare delivery. They are committed to excellence in design, safety, and efficacy, looking to bring on board a highly experienced Biomedical Engineer to help us continue our mission of advancing medical technology.
Typical Duties and Responsibilities
- Lead the design and development of medical devices, from concept through to market launch, ensuring products meet clinical needs and user requirements.
- Utilize electrical design software such as Altium Designer or Cadence Allegro to create and optimize circuit layouts for medical devices.
- Conduct Computational Fluid Dynamics (CFD) analyses using software like ANSYS Fluent or COMSOL Multiphysics to evaluate device performance and safety.
- Oversee the entire product development lifecycle, ensuring adherence to regulatory standards and quality management systems.
- Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure project success.
- Develop and maintain technical documentation, including design history files, risk assessments, and validation reports.
- Stay abreast of the latest trends and regulations in the medical device industry and incorporate best practices into product development.
Education
- Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, or a related field.
- Advanced degree or professional certification in Regulatory Affairs or a related discipline is highly desirable.
Required Skills and Experience
- 7+ years of experience in medical device design and development, with a strong focus on diagnostic instruments and surgical tools.
- Expertise in regulatory compliance, including knowledge of FDA regulations, ISO 13485, and other relevant standards.
- Proficiency in electrical design software, such as Altium Designer or Cadence Allegro.
- Experience with CFD software, such as ANSYS Fluent or COMSOL Multiphysics, for device performance analysis.
- Demonstrated ability to lead and manage complex projects in a multidisciplinary environment.
- Excellent communication and collaboration skills, with the ability to work effectively with internal and external stakeholders.
Preferred Qualifications
- Experience with wearable or implantable medical devices.
- Familiarity with wireless communication technologies and their application in medical devices.
- A track record of successful product launches and regulatory approvals.
