Design Control Engineer - 950 Circuits

Design Control Engineer – 950 Circuits Team

Fisher & Paykel Healthcare is a world leader in the design, manufacture and marketing of medical devices, exporting to over 120 countries globally. The 950 department is responsible for the development and delivery of our premium performance humidification system designed to be easy to set up and use, minimise condensate, and provide advanced protection. It is the gold standard in ventilator humidification.

We are seeking product development engineer to join our team in a design controls capacity. This is a critical role that will focus on accuracy, completeness, and compliance of project documentation across all stages of the design process, from initial concept to transfer to production.

Responsibilities:

• Manage design controls for product development, including the creation and maintenance of project documentation e.g. traceability, risk management, FMEAs & ECNs.
• Collaborate with cross-functional teams to ensure all documentation meets regulatory requirements and internal quality standards.
• Responsible for creating and maintaining product collateral such as user instructions & labelling.
• Work closely with other product development and quality systems engineers to ensure compliance with relevant standards, regulations, and guidelines.
• Maintain a high level of attention to detail, ensuring that all documentation is accurate, complete, and up to date.

Qualifications:

• Engineering or science degree is preferred, with experience in document control and quality assurance.
• Knowledge of relevant regulatory standards and guidelines (e.g. FDA, ISO, MDR).
• Strong organisational skills and the ability to manage multiple priorities simultaneously.
• Excellent attention to detail and strong analytical skills.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

If you are a highly motivated and detail-oriented person with a passion for design control and quality assurance, we want to hear from you!

At Fisher & Paykel Healthcare, we are committed to providing a diverse and inclusive workplace and encourage applicants from all backgrounds to apply.

Please submit your CV and cover letter highlighting your relevant experience in document control and quality assurance.