Lead Medical-Device Product Development

Fisher & Paykel Healthcare; New Zealand; On-site; NZD 150,000 - 210,000; Full time

Benefits offered by this job

Employee share purchase scheme

Bi-annual Profit share

Generous Paid Parental Leave

Life, Critical illness and Income/Dis.

Discounted Health Insurance

In-house training programs

Purchasing privileges for Fisher & Pay

School holiday programme subsidy

Banking and Insurance discounts

Free Parking

Beautiful campus with green spaces

Job summary

Fisher & Paykel Healthcare in New Zealand seeks a hands-on Product Development Manager to lead a small, experienced team through refinement and preparation for clinical evaluation of an invasive-ventilation interface product.

You will develop risk-based documentation, manage verification plans, work with regulatory and IP teams, and partner with external vendors to map manufacturing pathways and build a solid business case.

Qualifications

• Strong experience in medical-device product development.
• Practical understanding of medical-device documentation requirements.
• Strong leadership, planning and execution skills.

Responsibilities

• Create a lean, risk-based documentation set to support a Clinical Investigation and help manage the trial.
• Work with the IP team to secure patents protecting unique design features
• Develop and manage the product verification plan
• Work with external vendors to produce tooling and supply validation documentation.
• Liaise with the New Product Introduction team to map out a pathway for manufacture.
• Develop product costing to build a sound business case
• Work with the Regulatory team to understand device classification and country release requirements
• Set priorities, manage development risks and communicate progress and key decisions to stakeholders

Skills

Medical-device product development

Leadership & execution

Regulatory understanding

Job description

Fisher & Paykel Healthcare in New Zealand seeks a hands-on Product Development Manager to lead a small, experienced team through refinement and preparation for clinical evaluation of an invasive-ventilation interface product.

You will develop risk-based documentation, manage verification plans, work with regulatory and IP teams, and partner with external vendors to map manufacturing pathways and build a solid business case.