Product Development Engineer - East Tamaki, New Zealand - Fisher & Paykel Healthcare

Fisher & Paykel Healthcare

Verified Company

East Tamaki, New Zealand

1 week ago

Posted by:

Jack Simmons

beBee Recruiter

Description

About The Role
The Airvo Consumables Development team is responsible for developing lifesaving respiratory consumables for Airvo devices. Airvo consumables include patient interfaces and heated respiratory delivery systems.

Besides the business-as-usual activities that we need to support, our team also has several projects in areas of research and development, new product introduction, regulatory compliance and design changes.

There is an exciting opportunity for a detail-orientated person to join Airvo Consumables 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 control documentation for product development, including the creation and maintenance of project documentation e.g. traceability, risk management, FMEAs & ECNs.
Maintain a high level of attention to detail, ensuring that all documentation is accurate, complete, and up to date.
Collaborate with crossfunctional 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 Product Development, Quality, Regulatory and Marketing teams to ensure compliance with relevant standards, regulations, and guidelines required for market access.
Work closely with Operation teams on design transfer and production implementations.
Integrate the knowledge of product and regulations to devise effective strategies for compliance.
Project management of design changes etc.

Skills & Experience

Engineering or science degree is preferred, with experience in design control and quality assurance.
Exceptional attention to detail and strong critical thinking skills.
Excellent communication and interpersonal skills, with the ability to work effectively with crossfunctional teams.
Strong organisational skills and the ability to manage multiple priorities simultaneously.
Knowledge of relevant regulatory standards and guidelines (e.g. FDA, ISO, MDR) and previous project management experience would be advantageous.

Benefits

Employee share purchase scheme
Biannual Profit share
Generous Paid Parental Leave
Life, Critical illness and Income Protection Insurance
Discounted Health Insurance
Active Social clubs & community groups
Inhouse training programs from external providers
Purchasing privileges for Fisher & Paykel Healthcare and Medela products
School holiday programme subsidy
Banking and Insurance discounts
Free Parking
Beautiful campus with green spaces
Subsidised Café's
Annual Salary Review
High rates of internal promotion
Access to stateoftheart facilities

About Us

Fisher & Paykel Healthcare is a world leader in the design, manufacture, and marketing of medical devices, exporting to over 120 countries globally.

We are an iconic New Zealand company with a consistent growth strategy ensuring an expanding range of innovative devices for use in respiratory care, acute care and the treatment of obstructive sleep apnea.

We focus on nurturing a positive and inclusive culture based on trust and respect.

In New Zealand, our employee-led communities, Spectra (rainbow), Manaaki (Māori) and Women in Engineering play an important role in this culture.

We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organisations such as Diversity Works NZ, Pride Pledge and Global Women.

Requisition ID: 3786_
Posting end date: 16/08/2023_