WhiteSwell Limited is developing medical devices for the treatment of Acute Decompensated Heart Failure (ADHF). The company is a fast growing and dynamic organisation and the company reserves the right to change the job description, role, and reporting structure to meet the evolving needs of the business.
The Engineer will work as part of the engineering team and be responsible for tasks that are related to new product development projects. Initially, the Engineer will be focused on catheter component, process, and supplier development.
- Lead process and component development for novel devices and systems. Initially focused on the second generation of our ADHF therapy system.
- Generate device concepts within the project team to address product performance criteria.
- Develop test models for prototype performance evaluations.
- Build and test prototypes; analyse test data and interpret to identify optimal solutions to technical challenges.
- Strong design and technical ability based on a broad and deep knowledge of fundamental engineering principles and medical device processing technologies.
- Understand physician (user) techniques and clinical needs (disease state) and assist in developing product training materials.
- Research state of the art technologies that relate to the scope of the programme and identify technical capabilities that can advance and accelerate the company’s R&D projects and enhance product manufacturability.
- Implement DFM and DFA techniques into the design and development process at WhiteSwell.
- Evaluate, with the R&D team, the design and supply chain risks in the project and develop strategies to highlight, monitor, manage and mitigate these risks.
- Develop and implement component, process, test and design validation methodologies, protocols and reports.
- Complete tasks as designated by your supervisor and use project management tools to prioritise and manage these tasks effectively.
- Prepare reports, documents, procedures, specifications, and other such technical documents as required to ensure the success of the project.
- Support the development and deployment of best practices in the identification of risks to quality, risks to operations, or risks to new product introductions and initiating preventative steps in the project to mitigate these risks.
Qualifications, Knowledge, Skills, and Experience required:
- At least 2 years prior experience working ideally within a company whose products and processes are regulated and delivering results. Medical device industry experience is an advantage.
- Proficient in SolidWorks CAD design.
- Bachelor’s degree in Biomedical, Mechanical, Polymer, Materials, or Industrial Engineering. A Masters or PhD in a related field is highly desirable, or an equivalent combination of education and technical experience.
- Requires excellent written, interpersonal communication, and presentation skills and an ability to effectively present information to peers.
- A self-starter who is able to see and deliver the work required to advance the project with a minimal amount of direction.
- Holds themselves and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
Impact on the Company:
- Contributes to the success of the company’s products.
- Brings support and positive attributes to a culture that is respectful, supportive, goal oriented, scientific, and diverse.
- Supports colleagues in the achievement of their strategic objectives.
- Must be able to travel domestically and internationally by air and car, and work occasional weekends.
- Must possess a valid driver’s license and passport.
- The Research & Development Engineer is expected to develop and evolve his/her skills to stay abreast of the business and the evolving environment in which the business operates.