Manufacturing Engineer

Responsibilities

This role supports manufacturing operations in the areas of process development, tool

design, machine programming, machinery & equipment acquisition, manufacturing

layout, continuous improvement and other duties associated with engineering support of

production.

·       Provides technical support in identifying continuous improvements to manufacturing

operations and implementing new technologies including development of processes,

researching current and emerging technologies and evaluating process quality, cost,

capacity and capability alternatives.

·       Supports the needs of manufacturing areas in terms of meeting the requirements for

quality standards and compliant documentation, capacity, product availability and

cost.

·       Provides technical support regarding equipment design and development, testing of

materials, preparation of specifications and operator instructions, process studies,

investigations, root cause analysis, problem solving and report or presentation

preparation.

·       Performs assignments designed to continue the development of professional work

knowledge and abilities requiring application of standard engineering techniques,

procedures and criteria in carrying out a sequence of related engineering tasks, project

management, statistical analysis and presentation of data and technical writing.

Position duties & Responsibilities

·       Leads engineering projects that are less complex, either technically or with a small

cross-functional team. Leads and participates in projects including developing and

executing to the plan and schedule and meeting the goals and objectives of the

project. Tracks costs, prepares status reports, conducts meetings, and documents and

communicates progress to management.

·       Leads and participates in investigations, develops plans and executes tasks to solve

process problems including Nonconformances (NC), complaint investigations, audit

observations and Corrective and Preventive Actions (CAPA).

·       Provides day to day support and direction to production such as, but not limited to

turning, milling, drilling, EDM, finishing, packaging etc. as required.

·       Writes and executes engineering studies and process validation protocols and

summary reports (Installation Qualification, Operation Qualification, Performance

Qualification, Computer Software Validation and Test Method Validation).

·       Identifies and implements process improvements for existing manufacturing

processes utilizing appropriate engineering principles and standard strategies such as,

Lean and Six Sigma principles.

·       Performs gage design, measurement system analysis, and gage implementation as

required. Is able to use various types of measuring instruments including,

micrometers, calipers, comparators, tensile testers, coordinate measurement systems

etc. to support engineering testing.

·       Develops fixtures and designs tools and has the ability to express and implement

ideas with tool designers.

·       Supports new equipment acquisition efforts including user requirement specifications,

machine selection, installation, validation, employee training, and other related

equipment responsibilities as required.

·       Develops and implements manufacturing and inspection procedures.

·       Participates in, and, in some cases, leads cross-functional teams which may include,

but are not limited to Manufacturing Engineering, Production, Quality Assurance,

Finance, and Product Development.

·       Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and

their manufacture.

·       Performs other related duties, as required

Education & Experience:

·       2-4 years of experience in manufacturing and/or engineering is required.

·       Previous experience working in a regulated industry, such as Medical Device is

preferred.

·       Six Sigma or Lean Sigma certification or 2 years of experience preferred.

Essential:

·       Bachelor of Science Degree from accredited institution in Manufacturing

Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.

·       Demonstrates strong written, verbal and presentation skills.

·       Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab,

and databases.

·       Demonstrates strong organizational and project management skills and are results

oriented.

·       Demonstrates positive interpersonal skills and professional interactions with

coworkers.

·       Demonstrates troubleshooting skills.