Project Manager - Contract

What you will get to do:

• Support research and development team, consultants, and contract companies to ensure medical devices and equipment software are design and developed on time, within budget, and according to company procedures. 
• Lead weekly project tactical meetings to ensure weekly tasks are planned and coordinated. 
• Work with project teams to create and maintain development plans for projects from conception through commercialization. Collaborate with the project team to define project objectives, requirements, and assumptions necessary to structure a project or activity.
• Coordinate and track external development, testing, and production vendor timelines.
• Support preclinical studies including planning, preparation, and execution.
• Work with Quality, Clinical and Regulatory personnel to support regulatory submissions.
• Ensure all design and development activities adhere to regulatory requirements (e.g., FDA, ISO 13485, IEC 62304, MDR). 

What will make you successful:

Bachelor’s degree in an Engineering or Scientific related field required (master's degree preferred).
5+ years' experience in medical device industry, required.
Understanding of medical device regulations (FDA, ISO 13485, IEC 62304, and MDR), required.
Experience creating and managing project plans with critical chain project management tools, required.
Strong understanding of critical chain project management principles, including buffer management, preferred.
Experience managing 2-3 programs concurrently, preferred.
Excellent communication skills, capable of driving cross functional and global teams, preferred.
Ability to effectively manage scope changes and perform impact assessments, preferred.
Strong organizational skills with attention to detail, especially for regulatory compliance documentation, preferred.
Ability to adapt quickly in a fast-paced, evolving company and operate with a high sense of urgency, preferred.
Willing to travel up to 15% (may be required).