Manufacturing Process & Quality Engineering Lead – Medical Devices

Salary: $140,000–$145,000 per annum

Medical Devices | Manufacturing Engineering | Quality & Process Development The Opportunity An exciting opportunity is available for an experienced Manufacturing Process & Quality Engineering Lead to join an established organisation operating within the medical technology sector.

This hands-on technical leadership role combines mechanical engineering, manufacturing process development and quality engineering, with a focus on transitioning complex medical devices from prototype through to scalable, compliant commercial manufacturing.

You will play a key role in connecting R&D;, Manufacturing Operations, Quality and Supply Chain, ensuring manufacturing processes are robust, validated and ready for production.

This opportunity would suit an experienced engineer who enjoys solving technical challenges, driving continuous improvement and taking ownership of engineering projects from development through to implementation.

Key Responsibilities

- Lead manufacturing process development, optimisation and continuous improvement initiatives
- Drive Design for Manufacturability (DFM) and product improvement activities
- Support the transition of products from prototype through to clinical and commercial manufacturing
- Define equipment, tooling, fixtures and automation requirements
- Develop robust manufacturing processes, specifications and technical documentation
- Plan and coordinate equipment and process validation (IQ/OQ/PQ)
- Establish and monitor critical process parameters and quality requirements
- Apply Statistical Process Control (SPC), Cp/Cpk and process capability analysis to improve manufacturing performance
- Lead root-cause investigations, deviations and Corrective and Preventive Actions (CAPA)




- Support supplier quality, process validation and manufacturing improvements
- Ensure compliance with ISO 13485, ISO 14971 and FDA-aligned quality requirements
- Drive improvements in manufacturing yield, scrap reduction, downtime and operational efficiency
- Support MRP/ERP systems, manufacturing traceability and quality reporting
- Lead cross-functional engineering projects and provide technical guidance to engineers and manufacturing teams

About You We're looking for an experienced engineering skilled with a strong background in regulated medical-device manufacturing, particularly across mechanical design, manufacturing processes and quality engineering.

You will ideally bring

- A Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering or a related discipline
- 6–8+ years' engineering experience within regulated medical-device manufacturing
- Strong mechanical engineering knowledge, including design for manufacturability, tolerancing, precision assemblies, tooling and fixtures
- Demonstrated experience taking products from prototype through manufacturing scale-up and production transfer
- Hands-on experience with process and equipment validation (IQ/OQ/PQ)
- Strong understanding of ISO 13485, ISO 14971 and FDA regulatory expectations
- Experience with CAPA, root-cause analysis, deviation management and change control
- Practical knowledge of SPC,



process capability analysis and Design of Experiments (DOE)
- Experience developing manufacturing processes, equipment specifications and automation requirements
- Strong supplier quality and manufacturing process improvement experience
- Proven ability to manage complex engineering projects and collaborate across multidisciplinary teams
- Excellent communication, problem-solving and stakeholder management skills

Highly Regarded
- Lean Manufacturing and Six Sigma methodologies
- Advanced manufacturing automation and precision engineering
- MRP/ERP systems such as SAP
- Manufacturing KPI management, including yield, scrap, downtime and delivery performance
- Postgraduate engineering qualifications
- Experience working within dynamic medical technology environments
- Coaching and mentoring engineers or technical staff

Why Consider This Opportunity?
- $140K–$145K annual salary
- Take ownership of manufacturing process development and quality engineering activities
- Lead the transition of medical devices from prototype to commercial manufacturing
- Work across mechanical engineering, manufacturing, quality and supply chain
- Influence manufacturing strategy, equipment selection and automation development
- Collaborate with multidisciplinary engineering and technical teams
- Drive improvements in manufacturing performance, product quality and operational efficiency
- Lead technically challenging projects with direct impact on manufacturing readiness

Interested? If you're an experienced Manufacturing, Mechanical, Process or Quality Engineer with a strong medical-device background and a passion for taking innovative products through to successful manufacturing, we'd love to hear from you. Apply now with your CV for a confidential discussion.

📌 Manufacturing Process & Quality Engineering Lead (Perth)
🏢 Lead Group
📍 Perth