Program Manager, MDx (Wildcat) Diagnostic Hybrids
THIS JOB HAS EXPIRED Category: R & D MDx - Wildcat
This is an exciting opportunity in our Molecular Business Unit that will partner closely with the Wildcat instrument development team at Northwestern University! The Program Manager manages a medical device development initiative for Quidel and is responsible for managing project core teams for multiple platforms from phase 0 approval to product market introduction. Develops project resources, capital and expense estimates, maintains timelines and deliverables of the project core team utilizes Gantt charts, manages resource needs and cross functional team(s). Will manage outside relationships with design firms, write phase review documents, understands how to mitigate risks within the project and ensures compliance with our Quality System. ? 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 FMEA 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 engineering with at least 5 years experience in a clinical, diagnostic or equivalent industrial environment. MUST have demonstrated success in medical device project management. ? PM certification an added bonus but not required. ? Requires good analytical skills, ability to communicate well with all levels, and knowledge of timeline and budget management, FMEA and design control. 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 Program Manager 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).
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THIS JOB HAS EXPIRED