Having recently celebrated our 45th Year Anniversary, LABORIE Inc. is an international leader in the field of Urodynamics and Pelvic Floor Medical Devices.
With knowledgeable and driven staff headquartered in Toronto and within a number of offices in North America, Europe, and Asia (and 30+ distributors), we are an international company that drives innovation in the field of pelvic floor science. Our innovations are driven by working in close collaboration with leading doctors in various fields including incontinence, cancer, and sexual dysfunction.
As the world’s population ages and an emphasis on quality of life increases, LABORIE is at the forefront of driving to market technologies that not only help physicians do their jobs better and faster but also improves the lives of many suffering from pelvic floor disorders; to learn more, visit: www.laborie.com
Reporting to the Manager- PPMO Office, the Medical Device Project Manager is responsible for managing the company’s large-scale development projects. He/she will be leading and working amongst a cross-functional team of Engineers, Developers and Testers. A focus on achieving project success in terms of timeline, quality, scope and budget is essential.
The ideal candidate will be an experienced Medical Device Project Manager that can learn quickly and work with any member of the LABORIE team; he/she is a skilled communicator and problem-solver, has the ability to manage multiple competing priorities, and can contribute independently and as part of a team to achieving the company’s goals.
- Develop and manage large task-based interdepartmental project plans related to the development of Medical Devices and its related technologies. This role includes facilitating the team to define and achieve project goals and milestones from conception to post market surveillance.
- Assist in the establishment of Laborie’s Project & Product Management Office (PPMO)
- Follow LABORIE’s Design Control Procedure as well as all of its sub-processes.
- Assist in the development and continuous improvement of a GMP and ISO 13485 compliant Quality System specifically within the realm of Design Control.
- Direct and work alongside a multi-disciplined team including, Software, Mechanical, Electrical Engineers, Testers and Quality staff.
- Provide regular project status reports including risk assessments, contingency planning for risk mitigation and corrective action plans.
- Work with Engineering and purchasing in the identification of potential service providers, material suppliers and qualify same through a process of identifying and comparing availability, capabilities and terms.
- Negotiate contractual arrangements with potential vendors and service-providers for specific project elements.
- Administer contracts with vendors and service-providers to achieve project goals.
- Manage all aspects of project deployment including, but not limited to, quality reporting, schedule or budget variances, delivery risk management, and dispute resolution.
- Track various forms of project-related performance data using project-specific software applications and report on project progress to senior management.
- A minimum of 3 years experience in project management within the medical device industry; PMP preferred
- A minimum of 5 years experience in project management for electromechanical devices and/or software industries; PMP required
- A university degree in Engineering or Business required; Systems & Design OR Biomedical Engineering preferred
- Trained on ISO and GMP-level Quality Management Systems.
- A strong interest in the field of medicine, technology, and innovation.
- Strong technical writing capability and excellent oral communication skills.
- Highly developed analytical and quantitative skills.
- A meticulous working style including, the ability to focus on details while holding the end-goal in clear sight.
- Ability to subdivide complicated problems into smaller tasks, develop and implement actions to complete tasks to solve the larger problem.
- Negotiation skills and the ability to comprehend new information rapidly and integrate same to create successful outcomes.
- Highly organized with well-developed time-management skills and processes for managing priorities in one’s own work and that of others.
- Strong leadership and team-building skills, including the ability to assume responsibility and take independent action.
- Ability to take instruction and work as part of a corporate multidisciplinary team.
- Motivated self-starter with an ability to determine when to act and when to ask for support.
- Proficiency in the use of the office software including Microsoft Project and Visio.
We thank all who apply, but only candidates whose experience most closely matches our requirements will be contacted.
Indeed - 2 years ago
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