Senior Technical Operations Specialist

Senior Technical Operations Specialist

Our client a high potential start up are seeking Senior Technical Operations Specialist to join their team. The Technical Operations Specialist will support the development, manufacture and regulatory approval of a novel medical device technology. Operations will NOTAG both internal manufacturing and external subcontract manufacturing operations in a highly regulated medical device environment. Working with cross functional team to bring novel device through design, manufacture, testing, submission and regulatory approval and after scaling for commercialization. Working with the senior functional leads to develop the project scope and strategy and working with the functional teams to co-ordinate the detailed project plan associated timelines resources and project costs. The role will require strong Project Management experience and will have responsibility for the co-ordination of the planning, activity and assisting with execution of projects within the budget, timeline and scope. Set up and management of operations systems to support the current project, scale manufacturing and systems.



Role/Responsibilities:


Project Management

• Working with senior functional management to define the scope and project strategy.
• Working with the cross functional team members, identify a complete list of project tasks and requirements identifying the necessary resources, timelines and costs.
• Working with other stakeholders, vendors, subcontractors, service providers to manage project deliverables and execution.
• Develop detailed project plan to guide project team, vendors and other stakeholders and revising based on changing needs and requirements.
• Monitor project timelines, work with team members to ensure that all parties are on track with project requirements, milestones and schedules.
• Compiling and submitting project status reports to vendors, management and other stakeholders.
• Implement excellent leadership and communication skills to liaise effectively with all project stakeholders.
• Establishing effective project communication plans and ensuring their execution.

• Building and maintaining strong vendor and distributor relationships.
• Collecting and interpreting analytical and performance data to determine supply chain KPIs.
• Facilitate implementation of Supplier Agreements.
• Developing and implementing a comprehensive supply chain strategy.
• Working with vendors to ensure clarity on expected scope of work and delivery of such (in conjunction with R&D and Process Development). Some such vendors may include service and manufacturing vendors such as sterilisation, test houses, calibration services as well as product component manufacturers.
• Support and lead inventory management, warehousing/storage, and distribution
• Working with Quality to evaluate existing supply chain quality systems and other related processes to identify areas that need optimization and supporting optimisation efforts as well as further system development.
• Recommending and implementing supply chain improvements, as well as documenting processes.

• Planning of product builds including sterilisation and distribution.
• Establish production plans by converting a list of production requirements into a feasible production plan to ensure matched sets of materials and capacities are available to meet the company needs.
• Scheduling of production in conjunction with Process Development and R&D.
• Management of receipt requirements, WIP, remnants, rework. • Participate in company Health and Safety.
• Optimize facility layout and process flow.
• Planning of equipment preventative maintenance and calibration schedules. Benefits
• Opportunity to bring a new medical device to market to benefit patients, clinicians and healthcare systems.
• Competitive salary with bonus and significant opportunity to partake in company shareoptions scheme. • Working within a high-performance team providing support and great car