Technical Operations Engineer

Overview

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.

Position Summary:

The position reports to the VP of Technical Operations. The Engineer will work as part of the Technical Operations and R&D teams 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.

Responsibilities:

  • Lead process and component development for novel devices and systems. Initially focused on the second generation of our ADHF therapy system.
  • Support the VP of Technical Operations or designated supervisor on all matters related to the transfer of the R&D project to manufacturing partners and be a key member of the Technical Operations team for the Company.
  • Work to deliver the specification requirements defined by the R&D team.
  • 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 product manufacturability.
  • Implement DFM and DFA techniques into the design and development process at WhiteSwell.
  • Evaluate, with the R&D team, the technical and supply chain risks in the project and develop strategies to highlight, monitor, manage and mitigate these risks.
  • Attend weekly meetings and present progress to the VP of Technical Operations or designated supervisor.
  • Join R&D team meetings as required and contribute meaningfully.
  • Develop and implement component, process, test and design validation methodologies, protocols and reports.
  • Evaluate risks associated with the design and implement actions that mitigate these risks.
  • Manage sub-contractors, suppliers, and external parties.
  • Complete tasks as designated by your supervisor and use project management tools to manage these tasks.
  • Bring technical insight, innovation, process expertise, or other know-how to the projects of the Company.
  • 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.
  • Ensure that high quality product is delivered in compliance with procedures and the regulations.
  • Support the continuous improvement of yields, COGs, quality, and efficiency in the project and the business generally.

Qualifications, Knowledge, Skills and Experience required:

  • At least 2 years prior experience working ideally with a company whose products and processes are regulated and delivering results. Medical device industry experience is an advantage.
  • Good SolidWorks ability.
  • Bachelor’s degree in Biomedical, Mechanical, Polymer, or Materials 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.
  • Excellent communications skills: Can understand with ease virtually everything heard or read. Can summarize information from different spoken and written sources, reconstructing arguments and accounts in a coherent presentation. Can express him/herself spontaneously, very fluently and precisely, differentiating finer shades of meaning even in complex situations.
  • Has a solid grasp of team dynamics and is able to participate in teams that deliver outstanding results.
  • Holds him/herself 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.
  • Able to prioritize and focus on the few critical objectives amongst numerous project tasks and activities.

Impact on the Company:

  • Contributes to the success of the company’s products.
  • Reliable technical knowledge base on all Technical Operations matters.
  • 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.
  • Provides leadership example to employees across the group.

General:

  • 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 Technical Operations 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.