Senior Design Transfer Quality Engineer

Fisher Paykel Healthcare; Howick; On-site; NZD 96,000 - 106,000; Full time

Benefits offered by this job

Employee share purchase scheme

Profit share

Life insurance

Health insurance

Free parking

Job summary

Fisher & Paykel Healthcare is a world-leading medical device company based in New Zealand. This role focuses on quality engineering for NPI and capacity projects, ensuring process validation and design reviews align with the QMS.

You will apply FDA and international regulatory knowledge to help compliant product development and release. Cross-functional collaboration and continuous improvement are core to the role.

Qualifications

• Minimum of 5 years in medical device or highly regulated industry.
• Experience in quality engineering, design assurance, manufacturing or NPI.
• Understanding of FDA and international regulations and standards.

Responsibilities

• Provide quality engineering support for NPI and capacity increase projects.
• Act as the primary QA resource for process development teams and stakeholders.
• Assist with problem-solving, process validation, design reviews and releases.
• Drive continuous improvement initiatives within the QMS.

Skills

Quality engineering

Design assurance

NPI experience

Regulatory knowledge (FDA / ISO)

Job description

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.

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, assisting with 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 group comply with quality 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.

Why Join Us?

• Supportive Team:Be part of an experienced and collaborative team.
• Dynamic Projects:Gain exposure to multiple and diverse projects, facilitating rapid learning and professional growth.
• Cross-Functional Collaboration:Work with diverse teams, stakeholders, and functions, expanding your professional network and expertise.
• Employee share purchase scheme
• Discretionary bi-annual Profit share
• Life, Criticalillness and 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, 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 organizations such as TeUruTangata– 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 require support or adjustments during our process, please let us know at [e-mail].

This is a full-time, permanent position (40 hour week) with a salary range of $96,000 to $106,000. The role is based in our Auckland office in Highbrook Drive in East Tamaki.