Medical Manufacturing Engineer

DUTIES AND RESPONSABILITIES 2.1

Determine Processing Requirements to produce cost effective conforming product. 2.2 Create, edit, and support documentation efforts for process development and continual improvements (i.e. Work Instructions, PFMEAs Process Flow, etc.) as needed. 2.3 Create, edit, and support quality on dimensional inspections. 2.4 Determine, document methodology for inspection specifications for setting up inspections, to include but not limited to, gage designs and prints, etc. 2.5 Receives requests from staff and reviews drawings for accuracy prior to release to the floor, including but not limited to, creating/updating Exalta blank and in-process prints. 2.6 Evaluates data to identify deviation from specifications to communicate to management. 2.7 Develop manufacturing blueprints, routers, BOMs, and other supporting documents. 2.8 Create validation protocols based on Master Validation Plan and customer specific procedures execute approved validations protocols and create validation summary reports. 2.9 Support production flow of prototypes, verification runs, etc. Support initial production runs and support Design for Manufacturability reviews for customer feedback. 2.10 Design and develop tools, fixtures for standardization of processes for improved manufacturability and throughput. 2.11 Review and conduct root cause analysis on deviations that were identified during validation activities and resolve the deviated condition or justify why the deviation is acceptable. 2.12 Understand and work toward Engineering objectives, cost containment, process development, root cause analysis, data analysis, etc. 2.13 Evaluate and improve manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling and materials. 2.14 Manage projects and flow of the design transfer process through prototyping and into production including but not limited to reporting status, timeline development, etc.

KEY SKILLS, KNOWLEDGE, AND COMPETENCIES 3.1

General Knowledge and understanding of IS0 13485 and

FDA 21 CFR 820

as it pertains to process, inspection, validation, verification, design control, and documentation, etc. 3.2 At least 3-5 years of experience in Product Development, Quality Control, Quality Assurance and/or Manufacturing Process position at a Medical Device manufacturer preferred. Design and Machining experience a plus. 3.3 SolidWorks software knowledge and experience a must. 3.4 Minitab analysis knowledge a must. 3.5 Ability to read blueprints, customer/internal specifications, and procedures 3.6 Detailed knowledge of using precision measuring instruments. The instruments should include, but not be limited to calipers, ID and OD micrometers, depth gages, indicators, and plug and tread Go/ No Go gauges. 3.7 Detail Oriented as shown by documented measurement accuracy, to include but not limited to print reviews, document reviews, and organizational skills. 3.8 Proficient English communication skills- reading, writing, and speaking- as it relates to the job, Spanish a plus. Provide verbal instruction and training to the other personnel and operators on implementation of processes, inspection methods, performing validations, and proper documentation. 3.9 Skilled in basic math including but not limited to adding, subtracting, multiplication, division, and basic algebra for the purpose of calculating specifications and engineering calculations. 3.10 Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events while maintaining timelines. 3.11 Skilled in adapting to a changing work environment, competing demands and ability to deal with frequent change, delays or unexpected events while maintaining timelines. 3.12 Skilled in working independently, following through with assignments with minimal direction. Leadership skills a must. 3.13 Reasoning skills including but not limited to to comparing, classifying, analyzing and coordinating- minimizing duplication of effort. 3.14 Evaluate and improve manufacturing processes by applying knowledge of product design, fabrication, assembly, tooling and materials.

EDUCATION, CERTIFICATIONS, AND/OR LICENSES REQUIREMENTS

B.S. in Mechanical Engineering, Manufacturing Engineering or equivalent

PHYSICAL REQUIREMENTS

Ability to lift up to 50 lbs. and operate material handling equipment safely

PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS

Safety glasses on the manufacturing floor.