An exciting opportunity is available for a Senior Biomedical Engineer to join an innovative medical technology company.
This is a hands-on product development role combining mechanical engineering, medical device development, project leadership, usability and quality systems. You will take ownership of hardware development activities from concept and prototyping through verification and validation.
You will:
Lead the design, development and testing of medical device hardware, components and prototypes
Apply strong mechanical engineering principles to create robust, reliable and manufacturable products
Drive prototyping, simulation, physical testing and technical problem solving
Lead projects from concept through verification and validation
Coordinate project timelines, technical workstreams, suppliers and external partners
Contribute to usability and human factors activities, including gathering user requirements
Develop documentation including design inputs/outputs, V&V protocols and reports
Work within ISO 13485 quality and design-control processes
Support risk management, traceability, regulatory compliance and design reviews
Mentor and provide technical guidance to junior engineers
You will ideally bring:
Strong experience in medical device or regulated product development
Mechanical, biomedical, mechatronics or related engineering background
Hands-on experience in mechanical design, prototyping and product testing
Experience taking physical products from concept through V&V
Understanding of design for manufacture (DFM)
Experience operating within ISO 13485 or a comparable regulated environment
Knowledge of design controls, risk management and technical documentation
Strong project management and cross-functional collaboration skills