Sr Program Manager/Program Manager Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: New Product Development
We have two exciting opportunities for program managers. One position will partner closely with the Wildcat instrument development and assay integration teams at Northwestern University and the other will work closely with our new product development team(s) in San Diego. These roles lead cross-functional, medical device development projects from product concept through commercialization. This leadership includes coordination of multiple disciplines to create integrated systems, requiring in-depth knowledge of immunoassay, molecular and/or instrument program management. The program manager develops project resources, provides capital and expense estimates, maintains timelines and deliverables of the project core team utilizes Gantt charts, manages resource needs and cross functional team(s). Responsibilities include management of outside relationships with design firms, creation of system level design control documents, mitigation risks within the project and compliance with our Quality System. The program manager holds regular project team meetings and holds cross functional team members accountable to project goals. Works with staff to draw realistic but challenging timelines/priorities and provides follow-up/support on their timely execution. ? Responsible for coordinating team activities in accordance with Quidel's New Product Development Guidelines. Maintains timeline and design history files for the project. Works with functional areas to estimate expenses and track budget. Oversees development of design control, risk management, and other required documentation. ? Ensures appropriate representation on the project teams and committees as needed. ? Ensures communication of all pertinent information to all required levels and presents on overall project status.
? BS or equivalent in life sciences or engineering with at least 7 year?s experience in medical device / in vitro diagnostics product development and/or program management. MUST have demonstrated success in medical device / IVD project management. ? PM certification an added bonus but not required. ? Requires good analytical skills, ability to communicate well with all levels, and knowledge of design control, safety risk management, and timeline and budget management.. Maintains design history file. ? Excellent project management skills, prioritization, organization and the ability to multitask. ? Experience in QSR (Quality System Regulations). ? Experience with Gantt charts and timelines. ? Strong leadership skills and the ability to foster strong interpersonal relationships across work groups. ? Knowledge of the budgeting process, planning, and building realistic timelines. ? Strong knowledge of product development. ? The successful candidate for the Wildcat project will work closely with teams in multiple locations, so significant travel may be involved.
Quidel is proud to be an Equal Opportunity/Affirmative Action Employer (M/F/D/V).
Location San Diego , CA
Minimum Experience (yrs):
Required Education: Not Specified
||San Diego, CA |
THIS JOB HAS EXPIRED