- Experience Level
As Project Manager you will be responsible for managing the development of our medical device for transcutaneous electrical stimulation (Class III), towards CE mark and IDE approval.
- Build and maintain the project management plan
- Act as servant leader and coach, facilitating and guiding the work across the teams and suppliers
- Report on progress to the company’s management team on a regular basis
- Co-organize the project core team
- Organize and lead phase and design reviews
- Help manage risks and dependencies. Escalate and track impediments. Provide input on resourcing to address critical bottlenecks
- Involve in and manage the activities related to development, manufacturing, and validation at suppliers
- Co-manage clinical and marketing/market-access activities
- Support change management activities
- Listen and support teams in problem identification and decision-making, creating an environment of mutual influence.
- Encourage and support the personal development of each individual and the development of teams.
- Coach people with powerful questions rather than use authority
What we are looking for
- You hold a Bachelor or Master’s degree in biomedical or electrical engineering or similar, completed with a PMI, Safe Release Train Engineer or SCRUM Master certification
- You have relevant industry experience, experience in design processes as well as verification and validation of medical devices.
- You have proven experience in project management of complex solutions within multicultural teams, experience as program lead is a plus
- You have solid understanding & experience of ISO 13485, ISO 21500.
- You have experience in Medical Device/FDA Regulated Industry and compliance with IEC-60601 and ISO 14708.
- You have a basic understanding of clinical trials, marketing, and market access activities required for certification and market introduction of a new medical device
- You are results-oriented, hands-on and thrive well in an innovative, fast-paced and performance driven organization
Apply for the job
Do you want to join our team as our new Project Manager? Then we'd love to hear about you!
Empowered by movement, people with spinal cord injury will enjoy life in every way that matters to them. We are a team of scientists, engineers and physicians, collectively driven to create therapies that change lives. We understand the challenges of those living with spinal cord injury.
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