Manufacturing Engineer

Position Description:
Reporting directly to the Project Manager, this role is part of a growing team of 12-15 talented manufacturing engineers who are assigned directly to work on world changing projects. Once assigned to a project, this role works collaboratively with the Project Leader and Team on NPI efforts from concept to development through manufacturing transition with a focus on design for manufacturability and assembly. The role is responsible for process development, build development and transition to manufacturing. This key role requires cross functional effectiveness both internally and externally with the project team, customers, suppliers and partners.

Key Accountabilities/Objectives:
Acts as manufacturing representative from design concept through manufacturing on assigned projects. Provides technical expertise to drive process and build development and transition to manufacturing. Strong customer interface with goal of meeting or exceeding customer expectations.

Plans, conducts and executes pre-production builds, including developing assembly instructions, fixtures, line layout, and process FMEA’s.

Uses and applies knowledge and expertise to ensure design for manufacturability, repeatability and quality focus are incorporated into products.

Develops and maintains bill of materials, tool standards, shop floor control methods, process updates and executes engineering changes.

Creates and conducts test validation plans to qualify new or improved materials, processes, or products.

Works with customer to select and manage suppliers. Consults with suppliers to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluate products according to specifications and quality standards.

Key and primary interface with manufacturing partners to ensure products meet performance criteria, are made on time, on cost and within established quality parameters.

Qualifications:
Bachelor’s degree in Mechanical Engineering or Manufacturing Engineering with a minimum of 5-8 years experience working in manufacturing environments.

Knowledge and prior experience with component forming processes (injection molding, sheet metal / stamping / casting / forging / machining) and assembly processes (electronics assembly / welding / fastening / automation).

Strong understanding and prior successful experience using tools and applications to improve manufacturing efficiency – Six-Sigma, Lean Manufacturing, 6S, DFx.

Strong verbal and written communication skills essential. Role will work cross functionally across several organizational levels internally and externally.

Self-initiative, drive to complete deliverables and passion for solving challenging technical problems.

Experience in GMP for FDA-approved medical devices highly desirable.

Strongly prefer previous manufacturing fixture design experience.

Limited travel – 10% domestic and international.