We are currently seeking qualified candidates for a Project Management role with a global leader in immunodiagnostics. This is a permanent position that will be based out of the Bay Area, California, USA.
PURPOSE
The Diagnostics Project Manager is responsible for project management activities related to in vitro diagnostics product development programs. The position requires experience running complex projects within the product development environment, a natural aptitude for keeping track of multiple details, and strong planning and communication skills. The position will require both domestic and overseas travel from time to time.
RESPONSIBILITIES
- Work with the diagnostics program team to develop detailed timelines and scorecards to track the progress of diagnostics assays, software, and instrumentation through the design history process required for a successful launch in the US and abroad.
- Plan and track the development activities for FDA and CE approved products, including leading cross-functional teams and working closely with external hardware and software engineers and manufacturing vendors.
- Take accountability for the project plan, designing efficient tools that meet the needs of the program team and ensuring that all information is up to date and clear of obsolete documentation.
- Assist team members with the development of detailed activity plans consistent with key project milestones.
- Track progress of key project milestones and activities
- Anticipate potential deviations from the project plan, and work with the program manager and program team to implement corrective action as needed.
- Work with the program manager to ensure necessary decisions are based on the clear business goal of the project and that those goals are reached in a timely fashion.
- Identify potential project risks and develop contingency plans as needed.
- Regularly perform cost-exception analyses to identify factors and drive changes in forecast, then working with the program team to implement corrective action.
EDUCATION, SKILLS & EXPERIENCE
- Bachelor’s Degree in Chemistry, Engineering, Biological/medical life sciences or related field, or equivalent combination of education and work-related experience.
- Minimum 7-10 years of project management experience in the IVD Diagnostics or regulated medical device industry.
- Strong leadership and negotiation skills with a demonstrated ability to deliver complex projects on time through a team of professional colleagues in a manner that maintains a constructive atmosphere and positive team spirit.
- Natural aptitude for tracking and keeping control over multiple details, and a high need for order and clarity.
- Good understanding of the regulatory requirements for In-Vitro Diagnostic products, Good Lab Practice, ISO and QSR requirements.
- Demonstrated proficiency with MS Project, Excel, PowerPoint and Word programs is essential.
- Excellent communication skills, with an ability to understand and communicate technical scientific information to a wide range of audiences.
- Experience working with both cross-functional and international teams.
