New Product Introduction (NPI) Engineer

Role: New Product Introduction Engineer

Location: Auckland

Job Mission:

To enable the successful transfer of products currently made locally by Medifab and Artisan to third party manufacturers and suppliers, by preparing complete design, manufacturing and user documentation, and by owning the handover to the receiving manufacturer through to first production run. These products sit outside the ISO 13485 medical device scope, so documentation is governed by internal Medifab standards and ISO9001.

Responsibilities:

Product Transition & Compliance

• Lead the transfer of products currently manufactured locally by Medifab and Artisan to third party manufacturers, ensuring the receiving supplier has everything required to produce the product to specification
• Define and document product requirements, specifications and acceptance criteria for each product being transferred, to a level sufficient for a third party to manufacture and inspect against
• Carry out first article inspection, sample approval and pre production validation with the receiving manufacturer to confirm product performance and manufacturability
• Develop and maintain accurate engineering drawings and technical documentation for release to external manufacturers, including tolerances, materials, finishes and inspection requirements
• Create, structure, and maintain Bills of Materials (BOMs) within Odoo, ensuring data accuracy and alignment with production processes
• Translate existing informal or legacy documentation into structured manufacturing and technical documentation suitable for release to an external manufacturer
• Progress products through the internal transfer stage gates, from candidate selection through to first production run at the third party
• Own the handover to the receiving supplier or manufacturer end to end, including issuing the documentation pack, resolving technical queries, tooling and sample approvals, and sign off of the first production run, working with Design, Manufacturing, Quality and Supply Chain throughout
• Author and maintain user manuals, care and maintenance instructions, labelling and warranty information for each transferred product, and ensure products are documented to enable warranty support, traceability and spare parts availability
• Identify gaps in documentation, compliance, or process and proactively drive resolution to meet regulatory and operational standards
• Management of ECNs and ECOs as required based on market and supplier feedback.
• Maintain a Design History file for products ensuring all decisions and changes are documented correctly

Travel

• Travel within New Zealand, Australia and offshore as required to support supplier engagement, product transfers and manufacturer qualification

Qualifications and Experience:

Required Knowledge

• Working knowledge of design transfer and outsourced manufacturing processes, including supplier qualification and first article approval
• Understanding of product lifecycle documentation and design transfer requirements
• Familiarity with manufacturing documentation and product structuring

Required Skills

• CAD capability (SolidWorks or equivalent)
• Strong technical writing skills, including user manuals and instructions for use, with high attention to detail
• Ability to interpret and structure incomplete or legacy information
• Cross-functional communication and coordination

Required Experience

• Experience transferring products to contract manufacturers or offshore suppliers, including issuing documentation packs and approving samples
• Exposure to design processes, even if not in a primary design role
• Experience supporting product introduction, engineering change, or documentation control