Biosensor Engineering Project Lead Medical Devices | Product Development

AustCorp Executive; Western Australia; Sur place; AUD 140 000 - 195 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Mechanical engineering

Product design

Problem solving

Regulatory understanding

Project leadership

Formation

Degree in Mechanical/Biomedical/Mechatronics/Manufacturing Engineering

Outils

CAD software

Description du poste

Biosensor Engineering Project Lead

Medical Devices | Product Development & Manufacturing

Location: Perth WA

Employment: Full-time contract opportunity

Lead the development of next-generation medical technology

An exciting opportunity has become available for an experienced Biosensor Engineering Project Lead to join an innovative Australian medical technology business developing advanced biosensor technologies with the potential to transform patient monitoring and clinical outcomes.

This is an opportunity to play a key role in taking sophisticated medical devices from product development through verification, validation and manufacturing scale-up.

We are seeking a technically strong, hands‑on engineering professional who enjoys solving complex challenges, leading multidisciplinary projects and bringing innovative products closer to commercialisation.

The Opportunity

Working closely with engineering, quality, manufacturing and automation teams, you will take ownership of critical engineering projects, ensuring technical designs meet performance, regulatory and manufacturing requirements.

You will have the opportunity to influence product development decisions, optimise manufacturing processes and contribute directly to the future success of an emerging medical technology platform.

Key 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.

About You

We are particularly interested in candidates who offer:

• A degree in Mechanical, Biomedical, Mechatronics, Manufacturing Engineering or a related discipline.
• Demonstrated experience developing medical devices within a regulated environment.
• Strong mechanical engineering, product design and practical problem-solving capabilities.
• Hands‑on experience with ISO 13485, design controls and verification and 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.
• The ability to work independently and thrive in a collaborative, fast-moving environment.

Highly Regarded

• Experience developing Class II or Class III medical devices.
• Exposure to biosensors, electrochemistry, analytical instrumentation or sensor technologies.
• Knowledge of ISO 14971 risk management.
• Experience with manufacturing automation and IQ/OQ/PQ.
• Statistical analysis, design of experiments (DOE) or Python.
• Experience taking products from prototype through commercial manufacturing.

Why Consider This Opportunity?

• Work on innovative technology with meaningful clinical applications.
• Play a central role in advancing medical device product development.
• Gain exposure to the full product lifecycle, from engineering through manufacturing.
• Collaborate with experienced engineers, scientists and medical technology professionals.
• Join a growing organisation where your technical expertise and contributions can have a direct impact.

Interested?

If you're a technically driven engineer with a background in medical devices and enjoy the challenge of developing innovative products, we'd love to hear from you.