Our Melbourne based facility is seeking a New Product Introduction (NPI) Engineer to be responsible for the transitioning of newly developed microfluidic products into manufacturing through process innovation and collaboration with the product development and manufacturing teams.
This is your chance to join a rapidly growing multinational medical devices company working on the leading edge of medical diagnostics and life-science.
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.
Reporting directly to: NPI Team Leader
Essential Skills and Requirements:
- Significant experience (10+ years) working as an NPI Engineer.
- A tertiary qualification in mechanical engineering, or relevant
- In depth experience with product development and design methodologies and related
- 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
- 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
Key Responsibilities and Deliverables:
- Interpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry and business standards, and
- 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
- Maintain engineering process discipline to achieve project deliverables, including but not limited to; manufacturing strategy, capability analysis, FMEA, tooling selection, risk management, cost modelling, DFM, and process validation/qualification.
- Employ data driven tools and methodologies to implement structured and timely problem
- Identify opportunities and develop recommendations to improve product/design
- Develop and implement workflows to ensure best engineering practises within the Engineering Team
- Guide project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project
- Liaise closely with the Development and Manufacturing teams to successfully transition projects from Product Development into
- 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
- Effectively balance innovation with new opportunities and current capabilities to meet quality standards within a
- 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 with confidence and