Biotech Product Development Engineer — Regenerative Med

Australian Biotechnologies Pty; Sydney; On-site; AUD 110,000 - 150,000; Full time

Benefits offered by this job

Weekly wellness program

Health insurance

On-site parking

Career growth

Meaningful impact

Job summary

Australian Biotechnologies Pty, based in Frenchs Forest, NSW, is seeking a Product Development Engineer to design and develop advanced allograft solutions for orthopaedic and spinal surgery. You will lead development projects from concept to commercialization and mentor junior engineers.

Utilise your expertise in design control, risk management, ISO 14971, regulatory compliance, and biocompatibility to ensure safety and quality.

Qualifications

• Bio Med, chemical or Mechanical Engineering degree preferred.
• 3–5 years experience in Bio Med, FMCG or Pharma.
• Strong verbal and written communication skills.
• Proven leadership ability with mentoring junior engineers.
• Independent problem-solving and project management skills.
• Sound knowledge of regulatory pathways for Australia and major global markets.
• Familiarity with ISO 10993 and GMP cleanroom processing.
• Ability to compose clear, persuasive technical documentation based on scientific evidence.

Responsibilities

• Lead product development projects from concept through commercialization
• Implement risk management strategies in accordance with ISO 14971 and BS EN 62366
• Collaborate with cross-functional teams to identify resources and achieve project milestones
• Perform tolerance analysis, CAD modeling, and inspection of complex assemblies
• Prepare technical documentation, justifications, and regulatory submissions
• Support cleanroom processing and manufacturing activities as required

Skills

Leadership

Project management

Regulatory knowledge

Design control

CAD modeling

Risk management

Communication skills

Education

Bio Med Eng Degree

Tools

CAD software

Job description

Australian Biotechnologies Pty, based in Frenchs Forest, NSW, is seeking a Product Development Engineer to design and develop advanced allograft solutions for orthopaedic and spinal surgery. You will lead development projects from concept to commercialization and mentor junior engineers.

Utilise your expertise in design control, risk management, ISO 14971, regulatory compliance, and biocompatibility to ensure safety and quality.