Minifab is a world leading medical device development and manufacturing firm, specialising in creating custom made diagnostic and life science products for their strong client base, and manufacturing these cutting-edge products at their state-of-the-art facility located in Scoresby.
A unique and exciting opportunity has arisen for an experienced NPI Engineer to join the team on a full-time permanent basis.
The NPI Engineer is responsible for the transitioning of newly developed microfluidic products into manufacturing through process innovation and collaboration with the product development and manufacturing teams. This role encompasses the development and implementation of reliable, capable, and cost-conscious manufacturing processes to ensure new products are effectively transferred into volume manufacturing.
The Successful Candidate will be required to work alongside, and influence the outputs of product design, suppliers and manufacturing to deliver robust solutions within the project constraints of quality, timeline, and budget.
The key responsibilities of this role include: (but are not limited to)
- Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry and business standards, and regulations
- Develop Work Packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget
- Maintain engineering process discipline to achieve project deliverables, including but not limited to requirement definition, concept generation, product design and development, risk management, cost modelling, DFM, and design verification
- Employ data driven tools and methodologies to implement structured and timely problem solving.
- Identify opportunities and develop recommendations to improve product/design efficiency
- Develop and implement workflows to ensure best engineering practices within the Engineering Team
- Guide project teams through the selection of correct design/ manufacturing concepts and fundamental technology to ensure successful project outcomes
- Liaise closely with the BIO, NPI, and Manufacturing teams to successfully transition projects from Product Development into Manufacturing
- Organize plans and create schedules to identify priorities, achieve project timelines, and meet project budgets
- Support the recruitment, coaching and development of engineering staff to achieve excellence and efficiency
- Interact with clients on an as-needed basis to support project and sales activities.
- Collaborate with engineers, managers, and wider development, manufacturing, and purchasing teams
- Manage internal and external suppliers required to support product design tasks
- Attention to detail and self-motivation to deliver work to the highest standards
- Multitasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently
- Timely problem-solving using data driven tools and methods
- Presentation of designs and/or issues both internally to stakeholders and externally to clients.
Essential Skills and Requirements:
- Significant experience (10+ years) working as an NPI Engineer
- A tertiary qualification in mechanical engineering, or relevant discipline
- In depth experience with product development and design methodologies and related processes
- Extensive knowledge of injection moulding process, including polymer fabrication / prototyping techniques, and assembly / packaging methodologies
- Intimate understanding of Design control, Validation and Verification processes under a Quality Management System (ISO13485 would be ideal)
- Extensive and demonstrable experience with Design for Manufacture principles
- Experience working in fast paced, innovative, high quality, regulated, engineering environment such as medical device, food, automotive or similar industry is essential. IVD system development experience would be ideal
- A demonstrated competency in delivering design solutions for high quality, low cost, volume manufactured products
- Excellent attention to detail and self-motivation to deliver work to the highest standards
- Ability to multitask, plan, schedule, coordinate, manage time efficiently, and problem solve effectively
- Excellent written and verbal communication skills, teamwork and ability to take initiative
- Proficient computer skills, including Microsoft Office Suite
- Must be practically minded and hands-on
- Experience in internal and external stakeholder management at multiple levels
- Commitment to continuous improvement and proactive in sharing lessons learned.
If the above sounds like you, then hit the apply button and provide your CV and a cover letter.
Please ensure that your CV and cover letter are in Word Format (no PDFs).
Questions can be referred to Leah Creswick at Fuse Recruitment on 0478 193 170.
This is an outstanding opportunity for someone to join a rapidly expanding business and be part of ground breaking microfluidic product development that is changing the world.
Dare to think big.