
Project Manager I
- Arden Hills, MN
- $99,100 per year
- Permanent
- Full-time
- Provide day-to-day program leadership along with the CORE Tech Lead.
- Lead a core team comprised of cross-functional leads and subject matter experts from R&D, Operations, Regulatory, Clinicals, Commercial and Quality organizations.
- Work is expected to ensure scope of work, costs, schedules, and risks are properly planned, resourced, and managed from concept to commercialization.
- Build team ownership and commitment to project plan and identify, manage, and communicate project risks.
- Prioritize, delegate and manage tasks among team members as appropriate to drive execution of project deliverables and minimize risk.
- Interacts with internal and external stakeholders, by meeting regularly, responding to requests and explaining procedures.
- Develop project plans for changes and development including deliverable lists, risk management, literature and labeling, packaging, pre-clinical as well as build coordination of both development and formal test articles.
- Ensure the technical and regulatory integrity of the program and its verification and validation work and design reviews.
- Develop content that is in compliant with BSC, EU MDR, US FDA and global regulatory requirements.
- Work closely with the global commercial team and customers do capture user needs and support commercial launch.
- Report out and up project progress and status including presenting at Senior Leadership and possibly executive level product reviews.
- Demonstrates PDP/TDP system knowledge through coaching and delivery of high quality, high impact deliverables.
- Leads team to the successful completion of project goals.
- Bachelor’s degree in science or engineering and 7+ years of work experience in product development OR Master’s degree in Science, Engineering or Business and 5+ years of work experience in product development.
- Demonstrated project management experience leading cross functional teams and managing project scope, schedule, and budget.
- Excellent organizational skills, interpersonal skills, and strong verbal, written, and presentation skills.
- Strong Emotional Intelligence, situational leadership, and ability to manage by influence.
- Results-oriented, positive attitude focused on delivering timely, accurate and best in class execution.
- Comfortable communicating to and presenting in front of all levels of the organization.
- Proficiency in MS Office applications.
- Ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources.
- Excellent organizational, communication and collaboration skills.
- Experience in the medical device industry
- PMP Certification
- Experience with medical devices, hardware, and/or systems
- Experience with acquisitions and integration activities and/or working across different quality systems