Design Transfer Quality Engineer Manager
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 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 & Experience
We are looking for someone with:
- 5+ years demonstrated senior/ manager 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.
- Proven people leadership skills including experience in developing employees to ensure a highly motivated and performing team.
- 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.
Benefits
- Employee share purchase scheme
- Bi-annual Profit share
- Generous Paid Parental Leave
- Life, Critical illness 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 and Medela products
- School holiday programme subsidy
- 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
- Subsidised Café’s
- 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 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!
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 recruit@fphcare.co.nz.
Requisition ID: 3903
Posting end date: 11/10/2023