Job Description
Principal/Lead NPI Engineer/Team Leader - Regulated environment
Process Development and Validation
$competative salary + bonus
Introduction
An established global healthcare technology organisation is seeking a senior engineering leader to drive Process Development and Validation within its New Product Introduction function.
The company designs and manufactures regulated products that support safer clinical environments worldwide and is known for solid technical standards, disciplined execution and cooperative culture.
The Opportunity
This role provides technical and people leadership across a portfolio of new product introductions.
You will be accountable for building, leading and continuously improving the process development and validation capability to enable scalable, compliant and commercially successful global launches.
You will lead a multidisciplinary team of engineers and technical writers, influence manufacturing and product strategy from early concept through to launch, and partner closely with R and D, Procurement, Manufacturing, Quality and Regulatory teams to ensure robust and cost effective solutions.
Key Responsibilities
Lead process development and validation activities across new product programs to ensure readiness for commercial scale production
Contribute to manufacturing and sourcing strategy in partnership with R and D and Procurement
Influence product design to ensure manufacturability, cost effectiveness and alignment to business objectives




Oversee process qualification and validation from concept development through launch and early market ramp up
Build and develop a high performing team, strengthening technical capability and ownership
Drive cross functional alignment across Manufacturing, Supply Chain, Quality, Regulatory and Service
Embed continuous improvement principles including design for manufacture and assembly, design for inspection and lean methodologies
Establish and monitor meaningful engineering metrics and performance indicators within NPI
About You
Degree qualified in Engineering or equivalent industry experience
8 or more years experience within a highly regulated environment, ideally medical device or pharmaceutical
Demonstrated experience leading and developing engineers
Strong expertise in process development and validation, including structured validation strategy and execution
Commercially aware, with the ability to influence design decisions to balance quality, cost and risk
Excellent communication and stakeholder management skills, with the ability to lead through influence in complex organisations
The Environment
The organisation values technical rigour, collaboration and accountability.
It offers the opportunity to shape global product launches while working in a high impact, quality focused environment that values diverse perspectives and inclusive leadership.
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📌 Lead New Product Introduction Engineer (New South Wales)
🏢 ProFound People
📍 New South Wales