Job Mission:
To support the successful transition of new product designs into scalable manufacturing by bridging engineering and production, ensuring product quality, regulatory compliance, and efficient manufacturing processes. The Manufacturing Engineer will support product lifecycle management through investigation of field issues, engineering change management, manufacturing support, and continuous improvement of existing and new medical device products.
Accountabilities:
Transfer new product designs from engineering into manufacturing – Successful transfer of new product into production with complete documentation and validated manufacturing processes.
User matched product support – User matched inquiries responded to within 24 hours and design solutions submitted within 48 hours.
Manufacturing Efficiency – Implement and suggest design changes to improve the manufacturability of products.
Investigation and resolution of product issues – Timely investigation and documentation of customer complaints, warranty issues and non-conformances.
Technical documentation accuracy and control – Drawings, BOMs, specifications and technical documentation maintained current and compliant with quality systems.
Responsibilities:
Design and Manufacturing
- Support the transfer of new product development from design engineering into manufacturing.
- Assist in transferring manufacturing of new and existing products to third-party manufacturing partners.
- Lead technical investigation of product failures, manufacturing defects, and warranty issues, including root cause analysis and corrective action development. Escalate systemic product issues to the Compliance Engineer for regulatory review and lifecycle analysis
- Support corrective and preventive action (CAPA) investigations and implementation.
- Design and develop manufacturing jigs, fixtures, and assembly aids to improve efficiency and repeatability.
- Create and maintain detailed engineering drawings, product specifications, and technical documentation.
- Support user matched manufacturing requests including design adjustments, drawings and specifications.
- Maintain and manage Bills of Materials (BOMs) and ensure configuration control.
- Conduct product verification and validation testing where required.
- Train assembly and production staff on new product builds, processes and assembly requirements.
- Implement Engineering Change Orders (ECOs) within manufacturing processes including updates to BOMs, work instructions, assembly procedures, and production documentation.
- Collaborate with the Compliance Engineer to ensure manufacturing changes remain aligned with design control, regulatory requirements, and product risk management documentation.
Manufacturing Process Development
- Develop and optimise manufacturing processes to ensure repeatable, scalable production of medical device products.
- Design and implement manufacturing jigs, fixtures, and tooling to improve efficiency and assembly consistency.
Supplier Manufacturing Support
- Provide technical support to external manufacturing partners including product transfer documentation, troubleshooting, and process optimisation.
Qualifications and Experience:
Required Qualifications
- Degree Qualified in Engineering or Related Field
Required Knowledge
- Engineering principles related to manufacturing, product development and production processes.
- Understanding of regulated product environments, preferably medical devices.
- Product lifecycle management and engineering change control.
Required Skills
- CAD and engineering drawing creation.
- Problem solving and root cause analysis.
- Technical documentation development.
- Cross-functional collaboration with engineering, quality and manufacturing.
Required Experience
- Bachelor of Engineering (preferred)
- Experience working in the medical device industry (preferred)
- Experience supporting manufacturing processes, product transfers or engineering change management
