Shirley (CDP), MA Description:
Our client is currently seeking a Sr. Manufacturing Engineer for a 9 - 12 month + contract.
Medical device experience is highly preferred.
Support Manufacturing/Operations in the following areas: increase capacity, reduce scrap, improve safety, monitor existing processes, identify and implement process improvements in a regulated medical device reprocessing environment.
Sustain existing manufacturing processes, specifically the maintenance of manufacturing work instructions, layouts, and equipment.
Provide engineering support to trouble shoot and resolve technical problems.
Lead engineering projects and track project progress, present periodic status updates to supervisor, project teams, anticipate obstacles, and work to resolve them.
Design, procure, and qualify (IQ/OQ/PQ) fixtures, equipment, and tools as needed to increase efficiency, safety and ensure quality products at minimal costs.
Responsible for initiating, reviewing, documenting and approving Engineering Change Orders (ECO's)
Collaborate with other engineers to analyze manufacturing/assembly issues and identify, test, and implement the most effective solutions in a timely manner.
Ensure manufacturing documentation and process validation are complete, accurate and within GMP compliance.
Support and improve existing processes using statistical, lean, good manufacturing practices (GMP) and Six Sigma methodologies.
Effectively transfer new products, design changes or line extended devices onto the production floor.
Foster an environment of continuous improvement and provide support to customers in all functional areas.
Discuss progress and interim findings at periodic design/project review meetings.
Perform Failure Analyses (FAs) and improve Functionality/Performance of medical devices.
Implement process improvements and machining improvements on production lines.
Reduce Reject Rates(scrap)and optimize manufacturing processes.
Implement safety improvements on production lines.
Assist in the development and execution of technical protocols and, generation of reports.
Implement operating procedures, standard work, visual work instructions, and visual work references.
Assist with training to Production for all new product launches and design changes to existing products or processes.
Working with minimum supervision, conferring with superiors on unusual matters. Having some latitude for un-reviewed action or decisions.
Performing as a team resource - developing subsystem level design, development, testing and refinement.
Expectation of acquired knowledge of FDA/ISO requirements associated with the development of medical devices including Design Control.
Perform other duties as assigned or apparent.
Bachelor of Science in Engineering; Mechanical or Electrical Engineering preferred
2-5 years related work experience
Manufacturing experience in Medical Device or highly regulated industry highly preferred
Demonstrated mechanical/electrical problem-solving skills
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Proven ability to handle multiple projects and meet deadlines
Fluent in English
Demonstrated ability to operate small hand tools (e.g. pliers, screwdrivers, hammers, wrenches, etc.), power tools and test/inspection equipment
Excellent analytical skills and interpersonal communications skills.
Basic computer skills (word processing, spreadsheets, database).
Familiarity with Good Manufacturing Practices and ISO requirements preferred.Contact:
This job and many more are available through The Judge Group. Find us on the web at www.judge.com