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 strong technical standards, disciplined execution and collaborative 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.
Please reach out to for more info
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📌 Lead New Product Introduction Engineer (City of Sydney)
🏢 ProFound People
📍 City of Sydney
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