Manufacturing Innovator

Shape the future of medical device manufacturing at a cutting-edge organization.

Join a team on a mission to revolutionize cancer care. Our innovative technologies help providers deliver better, faster, and lower cost care for patients. We are approaching critical milestones in product development and commercialization. As we scale, we are seeking a dynamic and hands-on Manufacturing Innovation Leader to lead our manufacturing and process development.

Working closely with R&D, Design Assurance, Quality and Operations colleagues, you will provide manufacturing expertise to design, set-up and validate assembly processes. Above all, you will need to enjoy working in a fast-paced environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on-time to make real-world patient impact.

• Collaborate with R&D designers to optimize designs considering DFM & DFA principles.
• Lead the establishment of an assembly line within a class 8 cleanroom environment including jig and fixture design/setup.
• Validate equipment and processes for assembly of medical devices.
• Together with R&D and Operations support builds for R&D testing, product verification, process validation, clinical trials and commercial use.
• Own the creation of work instructions and in-process test methods based on design specifications and pFMEA requirements.
• Initiate process controls and data collection to enable real-time feedback on yield.
• Lead process failure and non-conformance root causing.
• Plan and manage project timelines for manufacturing projects.
• Work with existing and future external manufacturing partners to ensure processes meet time and quality expectations.
• Continually look for opportunities to optimize manufacturing processes through design and development.
• Use 3D CAD packages and in-house prototyping tools to design and create fixture concepts to aid assembly.
• Strive to meet and exceed expectations to deliver on quality, cost and timelines.

• Creative: A creative problem solver who is enthusiastic about new ideas.
• Open: Willing to adopt, engage with and shape company culture in a positive manner. You can give and receive candid feedback in a constructive and positive manner.
• Communicative: Strong written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.
• Self-Driven: You have a sense of urgency in your work, are resourceful and independent, and thrive when taking responsibility for tasks. You engage in ongoing personal development.
• Organised: You can prioritize your list of tasks independently and ensure actions are completed on time.
• Team Oriented: You enjoy working in a multidisciplinary team, all working towards a common goal.

• Qualification: Engineering or relevant technical degree.
• Experience: 6+ years relevant experience working within a manufacturing environment (with a minimum 3 years in the medical device industry) as a Manufacturing Engineer, Process Development Engineer, Project Engineer, or equivalent. Experience must include working within an ISO13485 QMS or equivalent environment.
• Optimizing assembly processes to improve throughput.
• Processing polymeric materials within a cleanroom environment.
• Installing and validating new equipment & processes.
• Root cause investigations and process analysis.
• Supplier Engagement: Comfortable and confident communicating and managing external suppliers.

• Engineering masters or further diploma in a relevant technical field.
• Processing PCBs & / or electromechanical components.
• Designing and configuring assembly spaces, prior startup or SME experience, and experience with rapid prototyping techniques including 3D printing, vacuum forming, and heat sealing.
• Supporting supplier process validations e.g. injection moulding.
• Line installations or line transfers, developing assembly processes from the ground up, and experience with Lean manufacturing tools and techniques.

Don't let experience gaps hold you back. With the right mindset, many of the skills above can be learned on the job. If this role excites you, apply now.