Process Development Engineer

At Ginan Bio, we are redefining the future of regenerative medicine. As a cutting-edge medical device startup, we combine biology, engineering, and innovation to create advanced solutions that accelerate healing and improve patient outcomes.

Our culture is collaborative, fast-paced, and purpose-driven — we value creativity, integrity, and scientific excellence. Learn more about our mission at

We are seeking a highly motivated Process Development Engineer to join our growing team at Ginan Biomedics.

In this hands-on role, you will design, validate, and optimise manufacturing processes that bring innovative medical technologies to market.

You will work closely with cross-functional teams, including R&D, Quality, and Operations, to implement scalable, efficient, and compliant solutions across tissue processing, packaging, sterilisation, and validation. You'll also play a key role in supporting the design and build of new manufacturing capabilities and facilities.

This position offers the opportunity to make a tangible impact in a fast-moving startup environment, helping translate scientific innovation into real-world products that improve patient outcomes. If you thrive in a dynamic, multidisciplinary setting and are passionate about medical technology, we want to hear from you.

This is a 12 month fixed term position for maternity leave cover.

Process Development

• Design and develop manufacturing processes, including tissue processing, packaging, sterilisation, and transportation
• Collaborate with R&D and Quality teams to implement efficient, scalable, and cost-effective solutions
• Understand design requirements and ensure manufacturing processes align with product specifications
• Support the seamless transfer of new processes into production
• Work with suppliers to ensure outsourced processes are robust and controlled
• Support the design and build of Ginan's manufacturing facility
• Create detailed process documentation, including work instructions, batch records, and other technical documents

Process Validation

• Assist in developing validation strategies for manufacturing processes
• Conduct risk assessments and implement mitigation controls
• Use statistical tools and methods to evaluate process performance
• Define and maintain production specifications

Continuous Improvement

• Identify and implement process improvements to enhance efficiency and reduce costs

Operations Engineering

• Troubleshoot manufacturing issues and identify corrective actions
• Ensure equipment calibration and maintenance schedules are followed
• Monitor key manufacturing metrics and performance indicators

Quality

• Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

Health and Safety

• Conduct all process development and engineering activities safely
• Maintain awareness of chemical handling and workplace safety procedures

• Bachelor's or Master's degree in Engineering or a related field
• Minimum 2 years' experience in a similar role, preferably in the medical device industry
• Strong understanding of manufacturing process design, validation, and risk management
• Familiarity with ISO 13485 and regulatory compliance frameworks desirable

• Highly motivated and self-driven, with strong attention to detail
• Excellent written and verbal communication skills
• Flexible and adaptable to changing priorities in a dynamic environment
• Analytical thinker with strong problem-solving ability
• Collaborative and respectful team player
• Eager to learn and open to new technologies

• Work at the forefront of medical innovation in a rapidly growing startup
• Collaborate with passionate scientists, engineers, and innovators
• Contribute to a supportive, agile, and mission-driven culture
• Play a key role in shaping the future of regenerative medicine
• Make a direct impact on the advancement of next-generation medical technologies