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    • Proven experience as a program manager or project manager, specifically in electronics, mechanical and industrial design projects.
    • You will play a key role in:
    • OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level.
    • Knowledge of medical device regulations (ISO 14155, EU MDR, 21 CFR).
    • Coordinate vendors, payments, and investigational device logistics.
    • Experience in the pharmaceutical, medical device or biotechnology industries is required.
    • Skilled at planning and tracking project activities and schedules.
    • Experience in healthcare, medical devices or regulated environments.
    • Develop detailed project plans including timelines, resourcing and budgets.

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Job Post Details

Project Manager - Med Tech/ Medical Devices - job post

Capgemini Sogeti
3.7 out of 5 stars
Melbourne VIC
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Location

Melbourne VIC

Full job description

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.

Your role

As a Project Manager specialising in the realisation of intelligent new medical device development projects, you will be responsible for leading and managing end to end execution of new- to- world development programmes orchestrating the interdependent fields of electronics, mechanical and industrial design.Please note experience managing medical projects and ensuring compliance with ISO13485 QMS is highly desirable for this role.

You will play a key role in:
  • Perform billable project management tasks, including developing project plans, defining task breakdown, and allocating resources.
  • Track project deliverables, monitor performance against estimates and budgets, and implement corrective actions when necessary.
  • Utilize established design and engineering processes, ensuring their effective application throughout projects.
  • Embrace stage-gated approach and development methodology, ensuring projects progress through the defined stages.
  • Identify opportunities for cost optimization and efficiency improvements without compromising the project's objectives or quality standards.
  • Adhere to Capgemini’s ISO 13485 compliance systems, ensuring projects are carried out in accordance with relevant regulations and standards.
  • Assist in Quality Management System (QMS) activities, including billable tasks during the development of medical devices, to ensure compliance.

Your profile

  • Bachelor's degree in a relevant field, such as Electronics Engineering, Software Engineering, Mechanical Engineering or a related discipline. Advanced degrees are a plus.
  • Proven experience as a program manager or project manager, specifically in electronics, mechanical and industrial design projects.
  • Proficiency in directing and managing established design and engineering processes.
  • Knowledge of ISO 13485 compliance and quality management systems is highly desirable.
  • Ability to embrace a stage-gated approach and development methodology.
  • Familiarity with medical device development is highly desirable.

Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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