Support new product/line extension team activities including:

Concept development and design input, timeline development, and design reviews and design for manufacturability

Assist in ensuring the QSR compliance of design control process in product development.

Knowledge or ability to learn DOE’s, process validations, and other QSR requirements.

Plan, coordinate and manage all manufacturing activities to launch and commercialize new products/line extensions including:

            Concept and development of all processes

            Concept, development and fabrication of all new tooling and equipment

            Coordination and support of all new vendor tooling

            Development and release of all product and process documentation

            Planning, ordering and management of component inventory

            Qualification and validation of all new operations and processes

New product cost estimates

            Preparation of the AFE

            Evaluation and recommendation of new materials

Plan, coordinate and manage all activities to transfer new products from design or Pilot to manufacturing including:

            Development and management of a transition plan and team

Documentation, methods and labor standards review

            Component inventory transition plan

            Facility selection, coordination and preparation

            Equipment moves and installation

            Validation and training support

Provide direction and guidance for CIP activities/contributions related to manufactured products.

Contribute as a key staff member in:

            Concurrent engineering efforts

            ISO procedures... Improvements and training

            Becoming the model organization for Bard

            Continuous improvement in quality, rapid product development

Hires, trains and coaches Engineers and Technicians to thrive in a results-driven environment.  Implements performance management duties including performance appraisals and salary reviews.

Travel required to manufacturing plants and vendors.

COMPUTER SKILLS:  Requires above average computer skills with experience in Microsoft Word, Excel, Powerpoint, Access, Microsoft Project, and various statistical software packages.

LANGUAGE SKILLS:  Good oral and written communication.  Ability to read, analyze, and interpret professional/technical journals, scientific literature, procedures, and governmental regulations.  Ability to write routine reports and business correspondence.  Ability to communicate well with individuals at all levels of the organization. Fluency in Spanish a plus.

MATHEMATICAL SKILLS:  Ability to perform basic engineering calculations.  Well versed in design of experiments.  Understanding of statistical concepts.

REASONING ABILITY:  Ability to solve practical problems and deal with a variety of concrete variables where only limited standardization exists.

1. When in doubt, the incumbent should source the appropriate information via internal and external resources.

:  Minimum of 10 years previous experience as a manufacturing engineer or process engineer.  Previous experience with airway products, catheters, and surgical products preferred.  Prefer knowledge of Mechanical, Plastic, or Chemical Engineering normally attained through a minimum of a 4-year technical degree. Upper level degree preferred. Extrusion, blow molding, injection molding, and dip coating experience preferred.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to sit, talk, and hear.  The employee is frequently required to use hands to handle and feel.  The employee must be able to lift or move boxes of product/raw materials.  Specific vision abilities required by this job.

No special work environment conditions other than exposure to chemicals and high heat in a pilot/manufacturing setting.