Product Development Engineer - Biotechnology

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 – Frenchs Forest NSW

Australian Biotechnologies is guided by a set of values; we demonstrate integrity by encouraging teamwork, we value relationships by showing respect and honouring customers and staff, we value performance by embracing safety, quality and innovation. These values define who we are and how we work. We encourage and support our employees to live these values every day, and we offer a range of benefits to help you thrive, including

Weekly staff wellness program.

• Health Insurance and gym discounts.
• On-site parking.
• Career opportunities to grow and develop.
• Rewarding job where you can make a difference by enhancing the lives of others.

Are you ready to lead innovation in regenerative medicine? Australian Biotechnologies, based in Frenchs Forest, is seeking a Product Development Engineer to design and develop advanced allograft solutions for orthopaedic and spinal surgery.

You’ll manage complex projects, mentor junior engineers, and collaborate across teams to deliver life-changing products. Using your expertise in design control, risk management, biocompatibility, and regulatory compliance, you’ll ensure the highest standards of quality and safety.

Enjoy a fast-paced development cycle where products move from concept to reality within one to two years giving you the unique gratification of seeing your work improve patient lives. With a proven track record of launching multiple products, this role offers both professional achievement and meaningful impact.

Key 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

Desired Attributes:

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

We are part of EBOS MedTech, which operates in nine countries through its portfolio of companies; Australian Biotechnologies (allograft manufacturing), Cryomed Aesthetics (aesthetic technologies), LifeHealthcare (ANZ medical device distribution), and Transmedic (medical distribution across SE Asia and Hong Kong).

Australian Biotechnologies – Frenchs Forest NSW

Australian Biotechnologies is guided by a set of values; we demonstrate integrity by encouraging teamwork, we value relationships by showing respect and honouring customers and staff, we value performance by embracing safety, quality and innovation. These values define who we are and how we work. We encourage and support our employees to live these values every day, and we offer a range of benefits to help you thrive, including

Weekly staff wellness program.

• Health Insurance and gym discounts.
• On-site parking.
• Career opportunities to grow and develop.
• Rewarding job where you can make a difference by enhancing the lives of others.

Are you ready to lead innovation in regenerative medicine? Australian Biotechnologies, based in Frenchs Forest, is seeking a Product Development Engineer to design and develop advanced allograft solutions for orthopaedic and spinal surgery.

You’ll manage complex projects, mentor junior engineers, and collaborate across teams to deliver life-changing products. Using your expertise in design control, risk management, biocompatibility, and regulatory compliance, you’ll ensure the highest standards of quality and safety.

Enjoy a fast-paced development cycle where products move from concept to reality within one to two years giving you the unique gratification of seeing your work improve patient lives. With a proven track record of launching multiple products, this role offers both professional achievement and meaningful impact.

Key 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

Desired Attributes:

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

We are part of EBOS MedTech, which operates in nine countries through its portfolio of companies; Australian Biotechnologies (allograft manufacturing), Cryomed Aesthetics (aesthetic technologies), LifeHealthcare (ANZ medical device distribution), and Transmedic (medical distribution across SE Asia and Hong Kong).