Responsible to design, analyze, develop, and qualify manufacturing processes, materials, tooling, and fixtures to meet manufacturing needs while enhancing productivity and product quality. Critical attributes and skills include technical creativity, initiative, ability to analyze problems, prioritize and negotiate priorities, use a hands-on practical approach, multi-tasking, and coordinating between groups within the company. The Manufacturing Engineer performs a variety of duties that involves engineering analysis and problem solving.
ESSENTIAL JOB RESPONSIBILITIES
Evaluates manufacturing process by collecting production process data, input from operators and equipment capability for analysis to support process improvements
Designs and develops manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality
Provides manufacturing decision-making information by calculating and analyzing production labor, and material costs.
Identifies, develops and implements process improvements and strive for continuous improvement and cost reduction
First responder for production process issues; troubleshoots and resolves production line issues.
Evaluates, selects, installs and conducts preventative maintenance of production equipment; troubleshoots equipment issues and coordinate equipment service as needed.
Responsible for all aspects of process validation to verify process implementation and verification (IQ, OQ, PQ) including protocol development, execution, and operator training and report writing
Interfaces with vendors for incoming components and resolving process issues
Incorporates statistical tools such as Gage R&R, Cp, Cpk, and SPC to improve processes
Utilizes lean manufacturing concepts to improve quality, labor efficiency, and throughput.
Generates implements and modifies manufacturing process documentation including Manufacturing procedures, routers, drawings and inspection procedures as needed.
Uses Project Management skills with ability to meet deadlines
Strong Protocol and report writing skills with strong statistical analysis capability
Works with cross functional teams including product development to support manufacturing transfer from R&D into production
Support product issues at incoming inspection as well as in process issues to resolve the issues within the quality system such as non-conforming materials and CAPAs.
Complies with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION & EXPERIENCE
B.S. in Mechanical, Manufacturing Engineering or other related Technical degree is required.
Minimum 2 years medical device experience is required. Experience with silicone molding and secondary processing preferred.
Must possess excellent written and verbal English communication skills.
Intermediate level skill in Solidworks, Microsoft Word, Excel, Outlook and other office software programs.
Strong statistical analysis
Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
Product testing experience
Experience with medical device manufacturing processes qualifications (IQ/OQ/PQ)