Planet Innovation (PI) is an award-winning medtech contract design and manufacturing company. We partner with leading global healthcare organisations and high-growth start-ups to create innovations that improve patient outcomes. Headquartered in Melbourne, with a growing presence in Irvine, California, we are expanding rapidly to meet strong demand across our client base.
What you'll be doing
As a Senior NPI Engineer, you will lead projects to establish or improve the manufacturing processes of a range of technically complex products (both medical and non-medical devices). You will possess a strong understanding of the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner. You will also be responsible for providing guidance to less experienced engineers on a broad range of manufacturing fundamentals and is expected to lead and drive continuous improvement initiatives across the manufacturing function.
Key accountabilities include:
About you
What we offer
What you'll be doing
As a Senior NPI Engineer, you will lead projects to establish or improve the manufacturing processes of a range of technically complex products (both medical and non-medical devices). You will possess a strong understanding of the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner. You will also be responsible for providing guidance to less experienced engineers on a broad range of manufacturing fundamentals and is expected to lead and drive continuous improvement initiatives across the manufacturing function.
Key accountabilities include:
- Lead, establish and improve manufacturing maintenance with a focus on lean assembly processes.
- Successful preparation of reports of key metrics and communication with clients and key stakeholder relationships at a peer technical level.
- Development of plans, schedules improvements for review and approval.
- Reporting of progress and status to agreed forecasts, plans and agreed outcomes.
- Technically responsible for product drawings, process flow charts, design reviews and feasibility risk assessments including relevant engineering documentation for products such as PFMEA, BOMs and SOPs.
- Participate in assembly processes within the manufacturing plant.
- Assessment and qualification of suppliers, including low-cost regions.
- Management of materials non-conformances and supplier improvements within the CAPA system.
- Ensure compliance with ISO 13485 manufacturing processes.
- Regular interfacing with engineers, suppliers and customers.
- Significant role in audit and qualification of suppliers and manufacturing processes.
About you
- Typically, has at least 8+ years’ experience within manufacturing function in engineering discipline.
- Experience in new product establishment and introduction into manufacturing.
- Knowledge of lean assembly and manufacturing techniques.
- Knowledge of PI engineering discipline framework, standards and methodologies.
- Compliance with international quality standards, including ISO13485, ISO9001 or having worked in a regulated industry.
- Bachelors in engineering (in appropriate discipline i.e. Mechanical; Electronics).
- Knowledge of cleanroom processes.
What we offer
- A collaborative, inclusive culture where your contributions are valued from day one.
- Exposure to technically complex, meaningful products, including medical devices that help people.
- Hands-on experience across the full NPI lifecycle in a structured engineering environment.
- A supportive team in our Box Hill facility with the tools and processes to help you succeed and grow.