Work Flexibility: Hybrid or Onsite

Based in NeuroHub, Model Farm Road.

Position Summary

This position is responsible for project managing (scope setting, project planning and execution) the implementation of all manufacturing processes and associated supply chain systems to support the development and commercial launch of new product programs on time, within budget and to required performance requirements. Working within the medical device quality management system, this leader manages a cross-functional team of professionals promoting collaboration and alignment within the team while simultaneously interfacing with both Commercial and Operational leaders to maintain organizational alignment through stakeholder management.

This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.

Key Areas of Responsibility

Sets the manufacturing strategy for the project gaining alignment with both Commercial and Operational leaders.
Delivery of the manufacturing element of new product programs, with specific focus on scope setting, project planning and management, product quality, budget management, product supply management and DFM (Design for Manufacture).
Provides strong, capable leadership to the project team encompassing of key professionals from Quality, Sterilisation, Production, Packaging, Labelling, Materials, Logistics, Finance, Industrial Engineering, HR, Process Engineering, Facilities & EH&S to ensure new product launch deliverables are achieved. Assumes overall responsibility for assigned teams and operational deliverables.
Collaborates closely with leadership at the manufacturing site during the design development phase to ensure that all new manufacturing processes are introduced into production compliantly, on time, within budget, are operationally successful, and in alignment with the broader plant manufacturing strategy. Ensures all required quality management system deliverables are met by the team to effectively transfer the product into commercialisation from the design development phase.
Develops a comprehensive communication plan and strategy to convey project status updates to stakeholders at both Commercial and Operational business forums.
Liaises with Regulatory Affairs to ensure the project strategy is aligned with the required regulatory pathway and appropriate regulations are met.
Supports supply chain strategy execution in collaboration with Global Quality & Operations partners and drives timely completion of sourced component qualification processes (PPAP) in alignment with QMS requirements.
Determines demand requirements and implements manufacturing capacity solutions in support of early product/process development, design/process validation builds and product launch activities.
Drives implementation of Lean Manufacturing throughout the project phases through to launch.
Drives capital acquisition strategy through determining total capital expenditure and operational expense, acquiring internal approvals, supporting contract negotiations and ensuring timely installation, qualification and validation efforts.
Identifies and escalates unresolved obstacles to the success of the project. Leads resolution of problems that impede project progress.
Establishes project priorities, imparting a sense of urgency and importance to the team while using project management tools and techniques to support delivery of project imperatives.
Participates in the selection, training, and performance appraisal process of project resources, including temporary contract SMEs, as required.
All other duties as assigned.

Qualifications Knowledge Skills

Bachelor’s Degree in Engineering or Science discipline or equivalent required. Project management certification through an accredited organisation (preferred).
Minimum of 7 years engineering / project experience in a regulated industry essential. Has demonstrated ability to successfully plan, prioritise, multitask and organise multi-disciplinary team(s) to successfully achieve project deliverables.
Has applied knowledge of FDA & International medical device regulations.
Ability to lead, motivate and influence a cross-functional team on moderate complexity projects that does not report directly to this position.
Strong communication and interpersonal skills with the ability to express ideas and collaborate effectively with multi-disciplinary teams.
Excellent analytical and problem-solving skills including risk management experience.
Experience in process validation preferred.
Experience with delivering results through six sigma and lean methods is preferred.
High level of PC skills required (MS Excel, PowerPoint and MS Project).

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Travel Percentage: 10%

Senior Project Manager, R&D

Job Description