Senior Design Transfer Quality Engineer
About The Role
Product innovation has been the cornerstone of our success since 1969, when our first prototype respiratory humidifier was developed. Today, our AIRVO products continue to lead the way in delivering nasal high-flow therapy for patients, ensuring the best of comfort and care with humidified air.
We have an exciting opportunity for a Senior Quality Engineer to join the Design Transfer Quality Team supporting our AIRVO product group. Working in partnership with our design manufacturing and engineering teams, you will support the design and development of new manufacturing processes to facilitate the introduction of new products to manufacturing.
You will be the primary quality assurance resource to process design teams, production support staff and stakeholders for problem identification, resolution, design reviews, and continuous improvement initiatives.
Your experience within the medical device industry and understanding of different manufacturing technologies will add value to this role and allow you to mentor junior members of the team.
And your understanding of international regulations (FDA, EUMDR, others) and standards, (ISO 13485 and ISO 14971, others) will assist the product group to meet our quality and regulatory requirements.
Skills & Experience
We are looking for someone with:
- A minimum of 5 years related experience gained 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.
- Understanding of FDA and international regulations.
- Experience in DFMEA, PFMEA, 8D, DFM.
- Diverse knowledge of inspection and control methods, techniques and documentation.
- Experience in Process verification and validation.
- A tertiary qualification in Science or Engineering (ideally industrial, bio-medical or electronic).
You will also have:
- Excellent communication skills with the ability to influence, negotiate and challenge with respect and diplomacy.
- An ability to build relationships at all levels within the organization.
- Strong leadership skills with the ability to work collaboratively and share knowledge across wider teams.
- Exposure to statistical analysis techniques.
- Familiarity with Regulatory requirements.
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: 3875
Posting end date: 28/09/2023