Our client is a Canadian leader in research and development of cutting-edge medical devices. Their facilities are second to none in North America which are propelled by brilliant engineers, designers, mangers and strategists that help bring ideas to fruition in the marketplace.
I am looking for either a Project Manager or Program Manager who has several years of experience in the creation of medical devices. This is a multi-faceted management position as you will be responsible for the project from concept and design through to the manufacturing and production process. It is critical to have a sense of urgency and strong management skills to bring these projects in on time and on budget.
- Lead design teams to develop new medical products and novel technologies throughout the product life cycle from initial concept through to detailed design.
- Initiate and steer effective brainstorming sessions that will spawn creative, open-minded, out-of-the-box thinking and creative business development ideas.
- Partner with Business Development to lead and/or support the creation of proposals and transfer of new activities into Engineering and taking full ownership of client relationships.
- Respond nimbly to changing circumstances and new information by assessing, recommending and applying design and project trade-offs (schedule, scope and budget) on a continuous basis
- Establish strong relationships with clients, team members, and vendors to ensure that schedules are met, and budgets are controlled
- Oversee the work of team members to ensure compliance with regulatory standards, company procedures, product requirements, and specifications.
- Ensure all required design and quality documentation is completed and all design processes are followed. Initiate and lead appropriate design reviews as required.
- Support vendor quotations, POs and lead times to monitor BOM targets and ensure cost-effective manufacturing processes are chosen during design.
- Creatively apply various project management approaches depending on the situation, be it lightweight frameworks that enable rapid iteration or robust deployments for established manufactured products.
- Continue to support products through the manufacturing transfer and ongoing production, including creating and managing ECRs, ECO’s, and liaising with clients to resolve product issues.
- Adhere to and enhance the Quality Management System (QMS), including developing and maintaining documentation.
- Engineering degree or equivalent combination of education and experience.
- At least five (5) years’ experience managing similar projects (with budget, schedule and scope accountability) is required to be successful in this role.
- Experience in leading combined hardware and software designs is desired. This includes CAD, PCB/Schematic Layouts, Embedded System Development, Software Development, FEA Analysis & modeling, rapid prototyping and Manufacturing processes.
- Previous experience as a Project Manager in a consulting environment (min. two to five [2-5] years managing external clients and projects) is desired and experience in a regulated industry, whether medical or not (e.g. aerospace or automotive) would be advantageous.
- Formal and demonstrated project management experience (PMP certification as an example); ISO13485 experience ideal.
- Supervisory experience is required.
- Contract management experience is required.
- Resource planning and management experience (e.g. labor forecasting and management) is required.
- Systems engineering experience is desirable.
- Some business development, sales and marketing experience is desirable.