Consumables Manufacturing Manager

Planet Innovation (PI) is an award winning Healthtech Innovation and Commercialization company, and we work on some of the most advanced technology in the world. We have our own portfolio of businesses, and also partner with world-leading organizations to help them create game-changing innovations to grow their business. Our clients include some of the world's top medical device and healthcare companies, as well as some of the world's most exciting start-ups.

Creating great products and winning awards is all down to our team. Planet Innovation has over 500 of the brightest and most passionate people on Earth, and we are looking for more.

We are looking for a Consumables Manufacturing Manager to manage PI’s Cleanroom operations and strategy.

**The Role**

The Consumables Manufacturing Manager is responsible for providing leadership in Cleanroom operations and strategy for PI. This includes leading and guiding the cleanroom service offering, from supporting New Product Introduction (NPI) and routine operations of the Cleanroom, to providing commercial leadership in new business development and client support. This role is also responsible for providing ongoing technical leadership in all elements of Cleanroom production and driving high-quality manufacturing outcomes.

**The Accountabilities**:

- Provide leadership and direction to PI with all elements of Cleanroom capability and drive manufacturing outcomes for consumable products.
- Ensure Cleanroom qualification per ISO14644-1 Class 7 of PI cleanrooms through quarterly BI and particulate testing.
- Continuous improvement and updating for all elements of Cleanroom operations including establishing, maintaining, and focussing on continuous improvement.
- General management of Cleanroom capability for PI including responsibility for P&L, cleanroom operations, and the upskilling and training of others in Cleanroom practices.
- Building and establishing both a direct and cross-functional team in Cleanroom capabilities.
- Having strategic oversight for future state Cleanroom activities, together with the day-to-day oversight.
- Leading and guiding the Cleanroom service offering for PI, including Business Development, New Production Introduction, and Strategy, coupled with day-to-day operational delivery.
- Leading Cleanroom process validation.
- Compliance with PI policies; procedures and international quality standards. Specifically, ISO13485 and ISO9001.
- Build commercial trust with clients and rapidly become their trusted advisor for Cleanroom operations.
- Supporting the Manufacturing General Manager in ongoing day-to-day issues and management of the function.
- Collaboration with the broader PI Manufacturing team in Melbourne and Irvine.

**The Typical Experiences**:

- Extensive experience in a similar Manufacturing leadership role, ideally within the medical or regulated industry.
- Technical leadership of cleanroom capability, with ISO 7 cleanroom experience.
- Leadership experience working with and influencing Executive Teams with Cleanroom direction and strategy.
- Strong commercial experience in the negotiation of agreements; such as supply and quality agreements, for contract manufactured products.
- Expert knowledge in processes such as Ultrasonic and laser welding, solvent bonding, tube cutting, cleaning and verification, and validation of cleanroom products.
- The ability to coach and train others in cutting-edge cleanroom techniques or capabilities.
- Sterilization experience, particularly with the Gamma and Ethylene oxide sterilization process.
- Cleanroom injection molding experience.
- Expert knowledge in risk assessment and high-volume process validation.
- Worked to recognised Quality Standards and Regulations including ISO13485, ISO9001, or having worked in a highly-regulated industry.
- Graduate degree in Engineering (i.e. Biomedical Engineering; Science; Software; Electronics; Mechanical; Mechatronics).

We are proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees, and all suitably qualified applicants will receive consideration for employment without regard for race, gender, sexual orientation, religion, disability, or age.

No recruitment agencies, please.