Lead, Design Transfer / QC Methods

Accelerate Diagnostics, Inc. Tucson, AZ
Design Transfer and QCMethods Lead

The Design Transfer and QC Methods, Lead (DT/QCM Lead) willprovide leadership within the Design Transfer/QC Methods team to ensure thatproducts developed by the Product Improvement or Engineering teams arevalidated and optimized prior to being transferred to the ConsumableManufacturing (CM) group for production. This person is responsible for the management,coordination, execution, and control of projects performed by the DesignTransfer and QC Teams to meet deadlines and project goals as directed by ProductRobustness Department Head.

Roles and Responsibilities:

* Develops and Initiatesinvestigations for Design Transfer and QC Methods for product improvements fromlarge and mid-scale projects and experiments.

* Manage projects that may reside withinmultiple product lines or sites as assigned

* Lead meetings with internal teams tofacilitate project completion.

* Preparation and management of a ProjectPlan to meet required milestones.

* Deliver the project within agreed upontimeline and budget.

* Provide notification of milestonecompletions to Senior Leadership.

* Provideoperational direction as related to project scope.

* Collaboratewithin a multi-disciplinary environment: engineering, software, lab, operationsetc. to bring devices to market.

* ManagesAssociate Scientist(s) and Research Associate(s) on daily activities andassignments


* Master'sdegree (PhD, preferred) in a relevant field or, minimum of 10 years' ofexperience in clinical microbiology or related industry settings.

* Proven ability to troubleshoot issuesas they relate to assays and instrument functions.

* Proven ability to prioritize and managemultiple projects

* Experience withproduct development under design controls.

* Leadership, negotiation, presentationand facilitation skills.

* Proven communication skills – bothwritten and verbal

* Experience withor knowledge of various commercial and conventional clinical microbiologysystems as well as emerging technologies.

* Experience inconducting risk assessments

* Experience inthe development of quality control testing methods

* Experience inanalytical chemistry

* Experience inimpurity/contamination detection techniques