The Company

The company is a growing medical device company focused on designing and manufacturing innovative orthopaedic solutions. Our team works at the intersection of engineering, manufacturing, and clinical application to deliver high-quality products that improve patient outcomes.

About the Role

We are seeking an experienced NPI Engineer to join our New Product Introduction (NPI) team. This is an exciting opportunity to play a key role in bringing cutting-edge medical devices from concept through to commercial production.

Working closely with Design, Manufacturing, Quality and Regulatory teams, you will lead and support the successful introduction of new products while driving robust manufacturing processes, quality outcomes and continuous improvement initiatives.

Key Responsibilities

- Lead the transfer of new products from design to manufacturing.
- Develop, implement and optimise manufacturing processes and work instructions.
- Plan and execute verification and validation activities, including IQ, OQ and PQ where applicable.
- Collaborate with cross-functional teams including R&D;, Quality, Regulatory and Production to ensure successful product launches.
- Lead risk management and design transfer activities in accordance with quality and regulatory requirements.
- Troubleshoot manufacturing and process issues during product introduction and production.
- Drive continuous improvement initiatives to improve product quality, manufacturing efficiency and cost.
- Prepare and maintain engineering documentation, technical files and design transfer records.




- Support regulatory submissions and compliance activities where required.
- Mentor junior engineers and provide technical guidance across the NPI team.

About You

- Degree qualified in Biomedical, Mechanical, Manufacturing or a related Engineering discipline.
- Minimum 5 years' experience in New Product Introduction, Manufacturing Engineering or Process Engineering, preferably within the medical device or another regulated manufacturing industry.
- Strong understanding of manufacturing processes, process validation and design transfer.
- Experience working within ISO 13485 and knowledge of FDA and/or MDR requirements is highly desirable.
- Excellent problem-solving and analytical skills with experience investigating and resolving manufacturing issues.
- Strong documentation skills and attention to detail.
- Excellent communication and stakeholder management skills.
- Ability to work independently while leading cross-functional projects.

Desirable

- Experience with orthopaedic or implantable medical devices.
- Knowledge of CAD software such as SolidWorks.
- Experience with risk management, FMEA and Design Controls.
- Lean Manufacturing or Six Sigma experience.
- Project management experience delivering new product introductions.

What We Offer

- Opportunity to work on innovative products that improve patient outcomes.
- Exposure to the complete product development and commercialisation lifecycle.
- Career development within a growing Australian medical device manufacturer.
- Team-oriented and supportive team culture.
- Competitive salary package commensurate with experience

Annual Salary of $80,000k

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📌 NPI Engineer (Sydney) (City of Sydney)
🏢 Konnecting Australian Skilled Migration & Recruitment Consultants
📍 City of Sydney