Design Transfer Quality Engineer Manager

Design Transfer Quality Engineer ManagerAbout The RoleProduct 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 anesthetic products) continue to lead the way in delivering humidified air for our patients, ensuring the best of comfort and care.We're looking for a people leader to join us as a Design Transfer Quality Engineer Manager.

Leading a large Design Transfer Quality Engineering team across a wide variety of projects and products, you will ensure the transfer of new product design into manufacturing for products within the RH product group by –Actively engaging with Process Development teams to ensure that product and manufacturing processes for new products meet design specifications and manufacturing requirements.Partnering with Design, Manufacturing and Engineering teams to support the design and development of new manufacturing processes to facilitate the introduction of new products to manufacturing.Ensuring products that are released for distribution meet specification through effective process verification and validation to ensure that the product's intended use can be consistently met.Ensuring adequate risk controls are in place through an effective risk management process to ensure products and processes are safe and reliable.Monitoring the external regulatory and industry environment, identifying and implementing changes which may impact on the Quality Management System and designing and implementing improvements to the QMS as and when required.Skills & ExperienceWe are looking for someone with : 5+ years demonstrated within design transfer and / or manufacturing experience, ideally in the medical devices industry, or a similar highly regulated market such as pharmaceuticals, military, airspace or aviation.Experience in Design or Manufacturing Quality Engineering and Transfer of product to manufacturing (NPI), including a deep understanding of the technical aspects of quality and knowledge of wider quality processes.An understanding of international regulations (FDA, EUMDR, others) and standards (ISO 13485 and ISO 14971, others), and a working knowledge of the regulations that apply to F&P.A working knowledge of statistics and process improvement tools.A tertiary qualification in Science or Engineering (ideally industrial, bio-medical or electronic).

You will also have : Effective communication skills with a strong ability to influence conversations, navigate complex discussions and resolve conflicts with a degree of pragmatism together with a high level of respect and diplomacy.An ability to build relationships of trust at all levels within the organization.Strong leadership skills with the ability to work collaboratively and share knowledge across wider teams.An ability to develop and maintain team objectives and KPIs aligned with F&P's long-term goals and strategies.About UsFisher & 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 (Maori) 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.If you're seeking a role with endless opportunities to develop, grow and advance your career, then apply now!

This is a full-time, permanent position (40 hour week) with a salary range of $110,000 NZD to $125,000 NZD.

The role is based in our Auckland office in Highbrook Drive in East TamakiRequisition ID : 5895Posting end date : 23 / 09 / 2025

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