Design Assurance 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 Quality and Regulatory Affairs. The Design Assurance Engineer will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development and maintenance of the design assurance activities to support product development projects.

Responsibilities:

Support the VP of Quality and Regulatory Affairs in the development and maintenance of a quality system in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
Represent the quality function at R&D team meetings and support the R&D team in meeting their objectives by providing advice and completing documentation reviews in a timely manner.
Support design assurance activities within the organisation preparing protocols, organising and supporting testing and preparing comprehensive test reports to support regulatory filings.
Participate in the risk management process to ensure that all risks are captured in the risk management report and ensure that all risks are mitigated in accordance with the requirements of ISO 14971:2019.
Lead biocompatibility activities for the project as required, in compliance with ISO 10993 standards.
Oversee and manage testing completed by external test houses on behalf of the company ensuring compliance with test protocols and all regulatory standards.
Prepare reports, documents, procedures, specifications, and other such technical documents as required in a clear manner to ensure the success of the project.
Lead and own CAPA as designated, drive root cause investigations and corrective actions for design assurance issues.
Support the quality and regulatory affairs department in quality management system reviews and in internal and external regulatory agency audits.
Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
Support the continuous improvement of quality system processes and the business generally.
Complete tasks as designated by your supervisor to support the needs of the business.

Qualifications, Knowledge, Skills and Experience required:

Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
At least two years experience in a quality engineering or regulatory role ideally in a regulated environment. Design assurance experience in the medical device industry is an advantage.
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 company goals 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.
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 expertise on all matters pertaining to the design assurance function.
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.
Is a positive role model to employees across the group.

General:

Must be able to travel domestically and internationally by air and car, and work / travel occasional weekends.
Must possess a valid driver’s license and passport.
The Design Assurance Engineer is expected to develop and evolve his/her skills to stay abreast of pertinent changes to all relevant standards and regulations.