3 months ago
MAIN PURPOSE OF JOB:
This position has the responsibility and authority to support the Manufacturing Engineering group: Develops, refines, and maintains new and existing manufacturing processes, including the creation of manufacturing processing documentation, equipment operating instructions, and product routers. Designs, constructs and maintains assembly fixtures and test equipment. Generates, collects and analyzes process data, prepares specifications, and evaluates materials and components. Qualifies and/or validates manufacturing processes and trains production operators. Identifies, qualifies, and executes quality improvement cost savings initiatives. This position is responsible for monitoring and improving medical product manufacturing lines.
MAIN JOB DUTIES/RESPONSIBILITIES:
. Designs, develops, and controls projects associated with the development of new, current, or acquired manufacturing processes. Participates in new product project team activity, supporting design for manufacturing elements.
. Designs, constructs, and maintains assembly fixtures and equipment supporting a Lean manufacturing environment.
. Generates, collects and analyzes data and prepares specifications, and orders materials and components.
. Qualifies or validates manufacturing processes and trains operators.
. Evaluates and provides input to manufacturing lines being released to production to help ensure the introduction of a capable and efficient operation
. Works with new process development engineering in the evaluation of new processes
. Evaluates release of process documentation for new processes
. Provides training and certification for trainers as required
. Drives a Quality focused culture by monitoring compliance to Quality System processes, such as system transaction compliance, documentation practices, non-conforming material, product holds, Line Clearance, etc.
. Participate in the corrective/preventative action process, as needed.
. Reviews product designs and manufacturing processes for the purpose of improving quality, reducing cycle time and controlling costs
. Plans and performs a wide variety of technical tasks to develop robust processes and solve non-routine complex manufacturing problems in an effort to maximize consistency, cost effectiveness, and productivity. Assist in project planning and budgeting.
. Collaborates in the design of all special production machinery (jigs, tools, fixtures, machines, and handling equipment) to maintain manufacturing operations at competitive levels
. Reviews process yields and tracts defects with the Quality Department against cost of quality
. Partners with other departments to ensure that the manufacture and purchase of components meet functional requirements at the lowest possible costs
. Limited travel will be required.
. Complies with the Quality System.
. Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
. Required to interact and communicate with peers and co-workers.
. Required to spend extended periods of time on computer-based work.
. Performs other duties as assigned.
Bachelors, Master's or PhD degree from an accredited school.
. Bachelor of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline required.
. Master of Science in Electrical Engineering, Mechanical Engineering or similar relevant discipline preferred
YEARS OF EXPERIENCE
Minimum of 4 years of experience in a medical device (aerospace or equivalent) manufacturing environment
SKILLS AND QUALIFICATIONS
o Experience in medical product manufacturing/assembly operations is a plus
o Knowledge in Continuous Improvement methodologies is a plus
o Experience with preventative/corrective action process
o Experience comprehending quality system process documents
o Experience interpreting mechanical drawings
o Experience with line layout, line balancing, and capacity analysis
o Experience understanding proper documentation/quality requirements for a regulated environment is a plus
o Aptitude for quickly learning and as simulating a broad array of information
o Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
o Understanding of development validation
o This position requires excellent oral and written communication skills
o Experience with Microsoft Office, and statistical software is required.
. PHYSICAL REQUIREMENTS
. The physical demands described within the main job duties / responsibilities section of this job description and representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
. During the course of regular assigned duties, the employee may be required to properly utilize personal protective equipment including but not limited to: safety shoes, safety glasses, goggles, hard hats, air purifying respirator or supplied air respiratory protection.
. The employee must be able to lift 35 pounds per job requirement.
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