Product Introduction Manager

1 week ago


Brisbane, Australia OneMD Pty Ltd Full time

Our client is a Medical Device start-up, developing a platform with patented inhalation technology to provide emergency treatment solutions for a range of indications including anaphylaxis.

They are seeking an experienced engineer with expertise across the full remit of the product development cycle and new process introduction. This position will have a particular focus on developing product concepts from initial prototypes to scaled high volume manufacturing utilising reliable processing methods.

A strong culture of collaboration, start-up mentality and challenging the status quo is emphasised within the business.

Position Overview:
Reporting to the Chief Technical Officer, this is an exciting role which will require leading with a significant degree of novelty or uncertainty, to deliver new capabilities for manufacturing.

**Responsibilities**:

- Deploy and develop mature and capable processes for new products including integration of new technologies (from complex equipment to simple jigs/test fixtures)
- Perform process characterization, assessment, and prototyping trials
- Utilise risk assessment tools (DFMEA, PFMEA etc.) to ensure project delivery and success
- Manage and engage with suppliers and external manufacturers
- Ensure engineering deliverables comply with regulatory and GMP requirements
- Determine qualification requirements and perform timely process validations
- Develop strategic documentation to support in managing the DHF and DMR
- Determine and document process steps; sequence of operations, test methods and incorporate these into a layout suitable for Lean production
- Recommend and implement actions to improve cost against targets
- Provide technical guidance to other engineers

Desired experience:

- 8 years+ of industry experience (Medical Devices preferably)
- Previous experience with injection moulding, joining, small part assembly would be advantageous
- Bachelors in relevant Engineering degree

What's on offer:

- Competitive remuneration package
- Unique opportunity to join a collaborative start-up environment



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