LOCATION:  Rochester, Ny

COMPENSATION:  105k neg + relo + benefit package

Participate in the deployment of DFSS on appropriate, world-wide product development projects with our client.

Work directly with the product development team including: in-bound marketing professionals, project managers, sub-team leaders, engineers and technicians, to train, coach and mentor the team members in the use of the DFSS toolset.

The position requires approximately 25% travel; more may be required during key project phases.

Ensure that the tools and methods of DFSS are being used for data-based calculation of the capability and robustness of the system and subsystem critical parameters (CPs) and that the Voice of the Stakeholder-to-Manufacturing process linkage is established for the appropriate critical parameters.

Mentor  employees and suppliers in the use of the DFSS tools and method.

Develop training DFSS material (i.e., QFD, DOE, Pugh, Regression); help plan, schedule, execute and ensure the quality of the DFSS training; update and maintain DFSS training material; develop B&L-specific training material (i.e., replace non-B&L examples with B&L examples); create “Quickset” of tools for implementation of individual tools.

Provide classroom-style DFSS training to  employees and suppliers.

Use DFSS on product development project, to help fulfill FDA/ISO design control requirements.

Act as gate-keeper at DFSS gate reviews.

Ensure that the DFSS tools and methods are being used on B&L product development projects.

Work with project managers, system engineer, sub-team leaders and internal/external team members to help identify the CPs and the noises that affect their means and variances.

Use DFSS to help fulfill PDMP requirements on product development projects; support the overhaul of the existing iPDMP, its training and deployment; map the DFSS CDOV process and tools into our client’s iPDMP; map CDOV gate reviews into iPDMP design/gate reviews; link CDOV deliverables to PDMP deliverables.

Ensure the capability of the associated measurement systems.

Identify the projects in which to deploy DFSS; determine the Green/Black belts on those projects; determine other non-project participants; manage the deployment of all appropriate DFSS tools and methods on specified product development project(s); ensure Champion, Green, and Black belts are identified, trained, and are executing their roles on the specific project(s).

REQUIREMENTS:

·        Minimum B.S. in electrical, mechanical, or software engineering, or a degree in the physical sciences. Masters degree strongly preferred

·        Minimum 10 years experience in product development, preferably in the design of regulated medical devices

·        Experience in the fulfillment of FDA/ISO design control requirements

·        Minimum of a DFSS or Six Sigma Master Black Belt certification and ability to demonstrate competency

·        Working ability of FDA/ISO Design Control regulations/guidance

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