Product Development Engineer

2 weeks ago


East Tamaki, New Zealand Fisher & Paykel Healthcare Full time

Become part of a rapidly growing team in the medical device industry at Fisher & Paykel Healthcare. Our group is developing innovative new products that are making significant advances in patient care and transforming the way patients are treated. We are seeking an experienced and highly motivated applicant to help us become a global standard of care through inspired, world-leading solutions.

It’s an exciting team to be a part of and your role will be a critical in ensuring we can continue to deliver our products to our growing customer base, as soon as possible.

This isn’t a usual Product Development role, and will see you supporting the following activities:

- Ensuring continuous delivery of products to our global customers, without commercial disruption by monitoring market regulations and maintaining compliance documentation for global standards, regulations, and guidelines
- Supporting product development engineering release activities
- Creating verification test protocols, tests reports and coordinating testing from our testhouses
- Collaborating with our Marketing team to provide effective customer-facing product collateral that meets market-specific regulatory requirements
- Developing strategies to register products in new markets as efficiently as possible
- Working with NZ and in-country Regulatory Affairs specialists to create successful regulatory submission packages for market approval

If you're someone who’s ambitious with a drive to deliver effective solutions in an ever-changing market and solve complex challenges for our industry, we want you to apply.

We offer you a unique opportunity to play a key role in growing an exciting new area of medical devices.

What We’re Looking For
- 2-3+ years+ of experience in engineering, regulatory, science, post-market, market access or legal is preferred, with experience in document control and quality assurance
- Strong organizational skills and the ability to manage multiple priorities simultaneously
- Excellent attention to detail, accuracy and completeness of documentation
- Strong analytical skills
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
- Strong verbal, written and presentation
- Prior experience with FDA, MDR or other relevant medical device regulations would be highly regarded

Why Work at FPH?
- Access to state-of-the-art facilities, including after-hours access for personal projects (eg: workshops, prototyping tools)
- Great team culture and work-life balance
- Access to experts across a diverse range of fields within the medical device industry
- Subsidised cafés
- 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
- Requisition ID: 3608_
- Posting end date: 17/07/2023_



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