Biosensor Engineering Lead — Medical Devices

AustCorp Executive; Western Australia; On-site; AUD 140,000 - 195,000; Full time

Job summary

AustCorp Executive is seeking a Biosensor Engineering Project Lead to drive the development of next‑generation medical devices from product development through verification, validation and manufacturing transfer. You will lead multidisciplinary teams and own critical engineering projects, ensuring designs meet performance, regulatory and manufacturing requirements.

The role emphasizes hands‑on mechanical and sensor engineering, ISO 13485 controls, supplier collaboration and product transfer to

Qualifications

• Degree in Mechanical, Biomedical, Mechatronics or Manufacturing Engineering.
• Experience developing medical devices within a regulated environment.
• Strong mechanical engineering, product design and problem‑solving capabilities.
• Hands‑on experience with ISO 13485, design controls and verification/validation.
• Familiarity with FDA regulatory requirements and medical device development processes.
• Experience managing multidisciplinary engineering projects and technical stakeholders.
• Exposure to manufacturing transfer, supplier management and production process improvement.
• Ability to work independently and thrive in a collaborative, fast-moving environment.

Responsibilities

• Lead engineering projects across medical device design, development, testing and manufacturing transfer.
• Manage mechanical and integrated product design, including CAD models, drawings, technical specifications and bills of materials.
• Drive design verification and validation activities in accordance with ISO 13485 and applicable regulatory requirements.
• Support technical documentation, design reviews, risk assessments and engineering change controls.
• Troubleshoot complex engineering challenges involving biosensor performance, reliability and product functionality.
• Collaborate with manufacturing and automation teams to improve processes, product quality and production efficiency.
• Manage technical relationships with external suppliers and manufacturing partners.
• Support equipment qualification, process validation and manufacturing scale-up.
• Coordinate project milestones, technical deliverables and cross-functional engineering activities.

Skills

Mechanical engineering

Product design

Problem solving

Regulatory understanding

Project leadership

Education

Degree in Mechanical/Biomedical/Mechatronics/Manufacturing Engineering

Tools

CAD software

Job description

AustCorp Executive is seeking a Biosensor Engineering Project Lead to drive the development of next‑generation medical devices from product development through verification, validation and manufacturing transfer. You will lead multidisciplinary teams and own critical engineering projects, ensuring designs meet performance, regulatory and manufacturing requirements.

The role emphasizes hands‑on mechanical and sensor engineering, ISO 13485 controls, supplier collaboration and product transfer to