Our Melbourne based facility is seeking a Scientist to work within the Bioscience department to design and execute assay related product development activities, within assigned projects, for the translation of biological assays and other biological processes into a microfluidic, IVD environment. In addition, this role is responsible for completing relevant product development documentation, estimating, and improving the performance and efficiency of existing systems and products. Throughout the product development process, the Scientist will collaborate with development, manufacturing, purchasing teams, and key suppliers on design projects, and present work both internally and to clients
This is your chance to join a rapidly growing multinational medical devices company working on the leading edge of medical diagnostics and life-science.
As required, the role will provide cross-functional support to Business Development and Manufacturing activities.
Reporting directly to: Head of Bioscience
Essential Skills and Requirements:
- Significant experience (minimum 5 years) with product or assay development under a Quality Management System with intimate understanding of Design Control, and Verification and Validation processes (ISO13485 would be ideal)
- A tertiary qualification (Masters/PhD would be desirable) in biology, biochemistry, immunology, molecular biology, biotechnology or life sciences related discipline.
- Demonstrated ability in data analysis, scientific report writing and presentation skills
- Sound understanding of GxP requirements
- Proficient computer skills, including Microsoft Office Suite
- Experience working in fast paced, innovative, high quality, regulated environment such as medical device, pharmacological, or similar industry is essential. IVD assay development experience would be ideal.
- 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, team work and ability to take initiative
- Must be practically minded and hands-on
Key Responsibilities and Deliverables:
The responsibilities of this role are (but not limited to):
- Interpret assay workflows and product requirements and work closely with the engineering team to develop and test design 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.
- Adhere to the 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 scientific practises within the PD process and cross-functional team activities
- Guide project teams through the selection of correct design/ manufacturing concepts and fundamental technology to ensure successful project outcomes.
- Liaise closely with the NPI Engineering 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 Bioscience staff to achieve excellence and efficiency
- Interact with clients on an as-needed basis to support project and sales activities.
- Collaborate with key stakeholders, managers, and wider product development, manufacturing, and purchasing teams
- Manage internal and external suppliers required to support product development 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.