Key Areas of Accountability New product development process: Oversee the creation and timely execution of new products via Design and Development Project Plans, creation of well-defined and effective product requirements, prototyping, process development, problem-solving and statistical/engineering analysis, protocols, reports and technical documentation, packaging development, verification and validation testing, usability and risk management, clinical evaluation activities and commercialisation activities for production launch and shipping – ensuring that the product transferred to production is capable of being on cost, on time and meets product and user requirements and quality and regulatory standards.
Project management: effectively manage multiple projects to time, quality and cost requirements.
Regulatory requirements: Ensure all new products meet internal processes (QMS), and external regulatory requirements.
Leadership: lead people and manage tasks for productivity, growth and continuous improvement in NPD.
Role Responsibilities Leadership Implement actions and initiatives as outlined in the Business Unit plan within areas of responsibility. Monitor potential opportunities and threats observed and keep your immediate leader informed of issues.Model effective personal leadership, organisational values and contribute to the development of a positive, collaborative culture by supporting agreed initiatives and practices.Ensure all teams within direct responsibility have adequate support and resources, and the team is proactively developed, mentored, and led to deliver against the business and growth objectives.Develop, contribute, and comply with all company policies and procedures.Any other duties, projects, or responsibilities as directed. Core role responsibilities Assist NPD Manager with NPD strategy, budgeting, and time management within NPD.Act up or be a delegate for NPD Manager as required by exercising sound judgment based on the company Mission, Values, and objectives defined by the NPD Manager.Oversee the new product development pipeline from product requirements to launch.Manage multiple projects developing and executing comprehensive project plans that include timelines, assignment of resources, testing, and key milestones for each new product development.Manage products and related processes within an ISO 13485 development and manufacturing environment and conduct tasks for compliance with FDA 21 CFR Part 820, EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), TGA regulations, and other as relevant.Contribute to the development and implementation of internal manufacturing processes and procedures that ensure the product undergoes valid testing (pre-production and throughout), including product drawings, work instructions, and quality inspection plans, including their control, updating, and distribution.Ensure the engineering practices continue to be compliant with the QMS, and that the product can consistently meet quality, safety, and effectiveness requirements. Continually observe and strategise for improvement in existing NPD processes.Collaborate across teams, including NPD, Tooling, process engineering, production, quality, regulatory affairs, supply chain, and sales and marketing, to ensure that new products continue to meet safety, effectiveness, compliance, and regulatory requirements, are viable to manufacture, meet customer needs and are suitable for market.Prepare technical documentation, plans, protocols, and reports for internal and external stakeholders, including regulatory agencies.Assist NPD Manager with observing and managing team performance, morale, and teamwork.Mentor and develop team members to build team skills, capabilities, and effectiveness. Appraise direct reports and contribute to wider-team member appraisals. Skills and Experience Education and Qualifications Degree in industrial design, mechanical engineering or similar.Project management certification desirable. Professional Experience 10+ years' experience in a similar technical role leading a team of professionals in product development in the medical device or other healthcare or regulated field.Strong understanding and ability to learn about legislation, regulations (TGA, FDA), QMS processes, and ISO requirements that underpin new product development of medical devices. Strong leadership and management skills, with the ability to lead, inspire and develop a team.Demonstrated skills in clear and effective data analysis and presentation using software such as Excel and MiniTab.Ability to run multiple projects and keep to time and costs. Skills and Knowledge A passion for advocating for the protection of patients and healthcare workers and for developing and supplying high-performing medical devices. Strong commercial acumen and understanding of business case methodology.Excellent communication skills with the ability to seamlessly tailor messaging to the target audience. Meticulous attention to detail.Comfortable working in a fast-paced environment and managing multiple priorities.Agile approach with the ability to quickly shift direction where needed.Ability to see the big picture and identify objectives at various levels that lead to company success.