Senior Design Transfer Quality Engineer

Fisher Paykel Healthcare; Howick; On-site; NZD 120,000 - 160,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit share

Life, critical illness & income保护

Discounted health insurance

Annual salary review

Free parking

EV charging facilities

Job summary

Fisher Paykel Healthcare is seeking a Senior Design Transfer Quality Engineer in Auckland to support NPI and manufacturing capacity, ensuring QMS compliance and robust product quality. You will collaborate with quality design, manufacturing and engineering teams to enable new processes and successful product introductions, supporting global medical device standards.

The role emphasizes regulatory knowledge (FDA/EU) and ISO 13485/14971 familiarity, with a focus on process validation, problem

Qualifications

• Minimum 5 years of experience in the medical device industry or a highly regulated industry.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• Understanding of FDA and international regulations and standards.
• Tertiary qualification in Science, Engineering or relevant discipline.

Responsibilities

• Provide quality engineering support for NPI and capacity increase projects.
• Act as the primary QA resource for process development teams, assisting with problem-solving, reviews, validation, design reviews and continuous improvement initiatives.
• Utilize knowledge of FDA and international regulations and standards to help the product group comply with quality and regulatory requirements.
• Ensure released products meet specifications through effective process validation.
• Design and implement continuous improvement projects for ongoing enhancement and compliance of the QMS.

Skills

Quality engineering

Design assurance

Manufacturing

NPI

Education

Science/Engineering degree

Tools

Regulatory standards

Job description

Jora New Zealand will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Fisher Paykel Healthcare – East Tamaki, North Island

Join a team of good people doinggood workwith intent.People like you, who care to make a difference.

About the Role

Product innovation has been the cornerstone of our success since 1969, when our first prototype respiratory humidifier was developed. Today, our Respiratory Humidification (RH) products, (encompassing respiratory, infant care and anaesthetic products) continue to lead the way in delivering humidified air for our patients, ensuring the best of comfort and care.

We are thrilled to offermultiple opportunitiesfor a Senior Design Transfer Quality Engineer to join our Obstructive SleepApnea (OSA) & Airvo DesignTransfer Quality Team. You will be working in partnership with our quality design, manufacturing, and engineering teams to support the design and development of new manufacturing processes and tofacilitatethe introduction of new products to manufacturing.

If you excel in a collaborative environment and aspire to contribute to our company's growth, we want to hear from you!

In this role you will:

• Provide quality engineering support for New Product Introduction (NPI) and capacity increase projects.
• Act as the primary quality assurance resource for process development teams, and other stakeholders, assistingwith problem-solving, reviewing process inputs, outputs, process validation, design reviews, process release, and continuous improvement initiatives.
• Utilize your knowledge of international regulations (FDA, EUMDR) and standards (ISO 13485, ISO 14971) to help the product groupcomply withquality and regulatory requirements.
• Ensure released products meet specifications through effective process validation, consistently aligning with the intended use.
• Design and implement continuous improvement projects for ongoing enhancement and compliance of the Quality Management System (QMS).

About You

• A minimum of 5 years of experience in the medical device industry or a highly regulated industry equivalent.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• An understanding of FDA and international regulations and standards.
• A tertiary qualification in Science, Engineering or relevant discipline.

Why Join Us?

• Supportive Team:Be part of an experienced and collaborative team.
• Dynamic Projects:Gain exposure to multiple and diverse projects,facilitatingrapid learning and professional growth.
• Cross-Functional Collaboration:Work with diverse teams, stakeholders, and functions, expanding your professional network andexpertise.
• Employee share purchase scheme
• Discretionary bi-annual Profit share
• Life, Criticalillnessand Income Protection Insurance
• Discounted Health Insurance
• Active Social clubs & community groups
• In-house training programs from external providers
• Purchasing privileges for Fisher & Paykel Healthcare products
• Banking and Insurance discounts
• Free Parking
• Beautiful campus with green spaces including EV charging stations and end of trip facilities to encourage lower-impact transport choices
• Annual Salary Review
• High rates of internal promotion

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, acutecareand the treatment of obstructive sleepapnea.

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 playan important rolein this culture. We also have a commitment to creating a positive lasting impact on society, shown by our support of New Zealand organizations such asTeUruTangata– Centre for Workplace Inclusion, Pride Pledge and Global Women.

We are dedicated to designing our recruitment process with care and empathy to support all candidates, regardless of identity, background, and experiences. Should you requiresupport or adjustments during our process, please let us know at *******@fphcare.co.nz.