Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.
Our vision is to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.
Please visit Nuclein.com for more information about our company's history, technology, and vision.
The Project Manager will lead planning, execution, and completion of projects related to the development and launch of medical devices. This individual will collaborate with cross-functional teams to ensure that projects are delivered on time, within scope, and in compliance with regulatory standards.
- Facilitate cross-functional team communication, representing all Product Development life-cycle phases including project planning, scheduling, tracking, coordinating, and monitoring activities
- Help create and manage project scope and schedule of complex development projects
- Work with stakeholders to clarify and maintain product requirements throughout the project life cycle
- Assure that all product and project deliverables (quality, performance, and schedule) are met
- Schedule and facilitate regular meetings to coordinate inter-departmental project activities; including those necessary to resolve project issues
- Facilitate the exchange of information among departments on a day-to-day basis and liaison with all members of the project team between project team meetings.
- Produce and present clear, concise, and professionally written communications and presentations for both internal and external stakeholders
- Interface with Department Managers as needed for resource management
- Manage project communications to all stakeholders (project teams, functional managers, internal and external customers, and senior management), including meeting minutes, monthly updates, communications meetings, and phase reviews
- Identify and implement process improvements to streamline time to market Participate in functional initiatives as dictated by business needs
- Bachelor of Science Degree, or equivalent years of education and experience required
- At least 3 years of industry experience managing projects across multiple teams and strategic objectives
- Strong analytical skills to assess situations and drive decision making
- Ability to coordinate across disciplines and integrate all aspects of business as they impact complex projects including negotiation of scope, roles and responsibilities, specifications, timelines, and resources up, across, and down the organization
- Ability to independently function in a fast-paced, dynamic environment
- Capacity to achieve outcomes based on ability to facilitate and negotiate desired results
- Impeccable organization skills, attention to detail, and punctuality are essential for this position.
- Self-motivated and able to work with minimal supervision
- Strong working knowledge of Design Controls (21 CFR 820)
- PMP certification preferred