Senior Advanced Manufacturing Engineer - Medical Device

Job description (Tasks/Responsibilities):

The Senior Advanced Manufacturing Engineer is responsible for detailed project management, engineering support, and direction for manufacturing activities to support the development and commercialization of new product and line extensions. Responsibilities: You will support new product team design activities including concept development and product performance specification input, project plans/schedules and design reviews and design for manufacturability. You will plan, coordinate, and manage all manufacturing activities to launch and commercialize new products including: concept and development of all methods and processes, coordination of all new tooling and equipment, coordination and support of 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 including DOE’s, validation protocol writing, execution, data analysis and executive summary reports, new product cost estimates, capacity analyses, preparation of capital appropriation requests, and evaluation and recommendation of new materials. Plan, coordinate and manage all activities to transfer new products from design 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 installations, IQ, OQ, PQ protocol development and execution, and validation and training support. Special projects as assigned.

Skill Requirements:

Bachelor’s Degree in Engineering required.  Masters Degree preferred. Minimum of three to five years of experience in design, machinery, assembly fixture, equipment and tooling procurement and design. Understanding and ability to execute DOEs, process validations, and test method validations. Understanding of cGMP’s and medical device regulations as they apply to manufacturing. Experience working with Active Pharmaceutical Ingredients (APIs) and medical devices. High level of written and verbal communication skills. Ability to conceptualize ideas, motivate and focus individuals and teams, and drive projects through completion on time and on budget. Minimal travel – 20%

Education Requirements:

Bachelor’s Degree required in Engineering or other technical discipline.

Location (City/State):

Warwick, RI

Company Description:

A market leader in comprehensive soft tissue reconstruction, delivering trusted products and techniques for hernia repair, specialized surgical procedures, fixation and biologic implants.

To Apply:

To apply, contact Tracy Wolfe at twolfe@zingaro.com or (512) 327-7277