- Apply knowledge of design control principles and quality engineering techniques throughout the product development process.
- Identify and manage risk using a FMECA and/or other risk management tools.
- Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
- Establish verification and validation strategies with R&D and Regulatory to assure an efficient approval path.
- Develop master test plans that encompass design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives.
- Provide input to design and manufacturing deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
- Develops, coordinates and conducts technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Apply understanding of anatomy & physiology with engineering knowledge in materials and processes to come up with designs.
- Interface effectively and build relationships with team members, other staff and key technology and component suppliers, both locally and globally.
- Qualified person to Bachelor/Master’s Degree level 8 in Mechanical, Biomedical or related engineering discipline and with a minimum of 2 years relevant experience.
- Dynamic team player and can work effectively and proactively on cross-functional teams.
- Collaborate across organizational boundaries and take appropriate actions when problems occur.
- Experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: risk management, component and system design, materials (polymers and metals), sterilization of medical devices, test method development, design for six sigma principles, pre-clinical evaluations, physician interactions, knowledge of anatomical use conditions (anatomy, physiology etc.), system requirements development, design control, application of ISO standards for medical devices.
- Good communicator and fluent in English, both in writing and speaking
- High level of enthusiasm and motivation, and the ability to take input from others are desirable.
- Understanding of mechanical-electrical medical systems, products, and therapies.
Or call Megan Warr on 091507515 for a confidential conversation