Extrusion Technician
Description:
Responsible for the day-to day operation of extrusion and downstream equipment, such as running of melt extrusion systems, assemble, disassemble, clean and inspect various components. Maintain records and data log sheets. Aid in process optimization to improve quality, yields, make recommendations, involving equipment modification, spare parts inventory and preventive maintenance procedures.
Duties
§ H• Implement production schedule and maintain quality within assigned area.
§ H• Extrude and process fiber / film / tubes to meet production requirements
§ H• Prepares and completes production paperwork.
§ H• Sets-up and operates extrusion machines
§ H• Set up and breakdown of extruder to include cleaning of dies, mandrels, pump, water tanks, etc and maintain records of setup.
§ H• Conduct preventative maintenance and CIP’s as needed.
§ H• In process testing to insure production and quality standards are met.
§ H• Test material in accordance with ASTM and USP standards including recording of data
§ H• Maintain good housekeeping and safety standards.
§ H• Must be flexible to work rotating shifts and available for call in when needed.
Requirements
High School diploma or Technical School
Excellent Microsoft Office skills
Candidate must have 3-5 years minimum experience in the assembly, set up and operation of extrusion equipment. Medical device work experience is a plus
Ability to lift 50 lbs; lower back strength and bending at knees and waist to lift as required.
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Extrusion Process Engineer
Description:
This position requires hands-on individual with fiber extrusion and processing experience within the medical device industry. The individual must be a self starter, able to work with minimal supervision and must be goal oriented.
Duties:
§ H• The development and commercialization of novel new biopolymer medical products.
§ H• The development of manufacturing processes and scale-ups into commercialization.
§ H• The development of equipment through proof of concept and implementation in manufacturing.
§ H• Responsible for the assembly, maintenance, set up and operation of extrusion equipment.
§ H• Development of processes to produce monofilament / multifilament for use in medical devices.
§ H• Development of medical textile processes and preparation of samples for various studies. y
§ H• Test material using yrheometry, melt flow indexing, tensile and fatigue.
§ H• Analyze test data and reports to determine conformance to requirement.
§ H• You will write, and execute test procedures and SOP’s. y
§ H• Research, develop, and evaluate materials, processes and/or equipment.
§ H• Conduct feasibility studies to verify capability and functionality.
§ H• Participate in quality reviews, E, I, O & P Q’s.
§ H• Maintain safe work environment and adhere to Quality System Regulation (QSR).
Experience:
5+ years minimum experience in the development of medical fiber extrusion with knowledge of validation and design control
Education:
PhD degree in engineering or chemistry is preferred. y Combination of education and experience will be considered.
Skills:
§ H• Specific understanding of fiber / tube / film extrusion and biopolymer rheology and process analysis.
§ H• Proficiency working with all types of extrusion equipment, hardware and control systems
§ H• Ability to work on problems that are diverse in scope, where analysis of data requires evaluation of identifiable factors.
§ H• Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact
§ H• Statistical design of experiments, process flow diagrams, device design controls, process simulation and other engineering software, etc. are preferred. High level of skill in Word, Excel and MS Project required
§ H• Basic mathematical modeling techniques and an understanding of statistics including design of experiments are important. Knowledge of statistic process control, six sigma, and other design for excellence methods will be a benefit
§ H• Good understanding of extrusion in theory and practice is a must
§ H• Team player motivated by success of the company, goal oriented, excellent communication skills, both written and oral
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Quality Engineer
Job Purpose
To provide Quality Engineering leadership through participation on project teams and the development and implementation of procedures, protocols, risk analysis, inspection and test methods. y Must be able to demonstrate leadership through collaborative efforts with the Operations and R&D functions within the company.
Duties
§ H• Review and/or create policies, procedures and work instruction relating to the Quality System
§ H• Represent Quality on project teams and ensure compliance with Design Control requirements
§ H• Develop Process Validation protocols and test reports
§ H• Lead and/or participate in risk management activities (e.g. FMEA)
§ H• Perform internal and external audits as required
§ H• Participate in the management of various aspects of the Quality System as required (e.g. Document Control, Calibration, etc.)
Qualifications
A minimum of a 4 year degree in a technical discipline with at least 2 – 4 years experience in the medical device or biotechnology industry.
Additional Qualifications
§ H• A thorough knowledge of QSR and ISO Quality System requirements with an emphasis on Design Control
§ H• Strong Quality Engineering skills with a proven track record developing process validation protocols, and FMEA’s
§ H• ASQ certification (CQE is preferred)
§ H• Familiarity with textile processing and testing is highly desirable
§ H• Auditing experience is desirable
§ H• Database management skills a plus
§ H• Must be a “hands-on” self-starter motivated by the success of the company and willing to assume a broad range of responsibilities as the company grows
§ H• Excellent written and oral communication skills
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QC Technician
Description:
This position requires an individual with the ability to perform multiple tasks within the Quality organization, including product inspection and administration of the document control and calibration programs among others.
Duties:
· I Maintains lot history records
· I Assist Quaity Engineering with process and product validation testing
· I Administration of the document control process
· I Create and/or approve quality inspection documents
· I Management of various Quality databases, e.g., calibration, MRB, CAPA, AVL
· I Input data and prepare reports as assigned
Experience:
A minimum of 5 years in a Quality function, preferably in the medical device A minimum of 5 years in a Quality function, preferably in the medical device industry.
Education:
A minimum of a high school diploma. y ASQ certification, CQT or CQI is highly desirable.
Skills/Knowledge/Experience:
· I Knowledge and good comprehension of FDA’s Quality System Regulation (QSR) and ISO 13485:2003 and/or ISO 9001
· I Good metrology skills
· I Well organized with good recordkeeping skills
· I Ability to work well with others and to communicate effectively
Additional Qualifications:
· I Ability to read and understand engineering documentation
· I Familiarity with PC based software for data entry and report generation
· I Auditing experience is a plus
· I Knowledge of statistical sampling plans and statistical techniques for the analysis of data
Position Type: y y y y y Salary
Shift: y y y y y y y y y y y y y y y y y y y 1st
Reports to: y y y y y y Director of Quality Systems
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