FMI Technologies Careers

Careers

Equal Employment Opportunity Policy

FMI Technologies Inc. is firmly committed to a policy of equal employment opportunity. Accordingly, the company will administer its human resources policies and conduct its employment practices in a manner which treats each associate and applicant on the basis of merit, experience and qualifications without regard to race, color, religion, sex, national origin, age or veteran status. Moreover, an otherwise qualified individual will not be discriminated against because of his/her disability or handicap.

Affirmative Action Policy

FMI Technologies Inc. has always maintained and will continue to maintain its policy to recruit and hire employees without regard to sex, race, color, age, disability, national origin, religion or ancestry.

Cable Assembler

Electromechanical Assembler

DATE – 2/6/2012

JOB TITLE – Electromechanical Assembler DEPARTMENT – Manufacturing

ORGANIZATION DESCRIPTION – – If you possess an entrepreneurial spirit and are a self-starter we will provide an exciting working environment in a highly innovative and motivated team environment! FMI Technologies Inc. is a startup international company designing and manufacturing new medical devices for use in the US and Chinese markets.

DUTIES & RESPONSIBILITIES –
• Read blueprints, wiring diagrams, schematic drawings, & engineering instructions for assembling electronics units, applying knowledge of electronic theory & components.
• Build, calibrate, maintain, troubleshoot & repair complex electrical, electronic & electro-mechanical systems and prototypes according to engineering data & knowledge of electrical, electronic & mechanical principles, using hand tools, soldering iron & measuring instruments.
• Set up & operate test equipment to perform in-process & final testing on parts, assemblies, or systems under simulated or actual operating conditions, & record results.
• Track & order supplies/materials.
• Collaborate with engineers and other personnel to identify, define, and solve problems.
• Provide technical assistance & guidance to other technical personnel.
• Continually improve manufacturing processes & procedures.
• Assist with the installation, debug & validation of process equipment.
• Contribute to the development of work instructions, records, logs & other device history documents.
• Maintain a clean & safe work area.
• Understand & follow all relevant regulatory agency requirements, follow all safety guidelines & report unsafe conditions to supervisor.

SKILLS –
• Understand principles & theories of electronics, mechanics, electrical circuitry, basic engineering mathematics, electronic & electrical testing, & physics.
• Excellent written & verbal communication skills in the English language.
• Ability to effectively manage time & complete all tasks as assigned by supervisor.
• Effectively use basic office applications such as MS Word & MS Excel.
• Fluent in English; ability to read and write Chinese (Mandarin) is an asset.
• Above all the candidate must be fair, ethical & possess a high degree of integrity.
• Experience with QSR/FDA ISO 13485:2003 or other highly regulated assembly\test environment is an asset.
• Computer networking knowledge is a plus.

EDUCATION – Associate (two-year technical) degree, a diploma from a technical or vocational school or equivalent military training or equivalent combination of education & experience in electronics.

EXPERIENCE – Minimum of three years of experience in electro-mechanical assembly/test work.

PHYSICAL REQUIREMENTS –Must be able to walk, sit and/or stand throughout an eight or ten-hour day.
• Must be able to consistently lift 50 lbs. from a floor or table position to chest high using a proper lifting technique.
• Some operations require the operator to push and/or pull objects to a machine or/on a cart.
• Must be able to repetitively use arms, hands, & fingers in the manipulation of parts.
• Must demonstrate good hand/eye coordination & good manual dexterity.

To apply for this position forward your cover letter/resume/salary requirements to FMI Medical Systems, Inc.,
526 S. Main St., Suite 812, Akron, OH 44311 Attention: Human Resources,
email to FMI.Humanresources@fmimaging.com or fax to 330-253-0201

Incoming Receiving & Inspection

DATE – 2/6/2012

JOB TITLE – Incoming Receiving & Inspection DEPARTMENT – Manufacturing

ORGANIZATION DESCRIPTION – If you possess an entrepreneurial spirit and are a self-starter we will provide an exciting working environment in a highly innovative and motivated team environment! FMI Technologies Inc. is a startup international company designing and manufacturing new medical devices for use in the US and Chinese markets.

DUTIES & RESPONSIBILITIES
• Physically receive incoming material shipments at dock and move to Receiving Department.
• Perform inspection of incoming shipments for conformance to Purchase Order.
• Use computer to check in and receive materials using PCMRP system.
• Interface with Purchasing, Manufacturing, Accounting and Engineering personnel.

SKILLS
• Computer literate
• Ability to lift heavy objects
• Tow motor certified

EDUCATION
• Associates degree (2 year), preferably in Electronics Technology.

EXPERIENCE
• 3+ years experience working in warehousing, receiving, inspections or inventory position
• Ability to move incoming materials to receiving room, read packing lists and physically inspect incoming shipments
• Experience in working with computer MRP system preferred.

TOOLS/EQUIPMENT USED –
• Ability to use pallet jack, two-wheel dolly, tow motor and other receiving equipment.
• Computer

To apply for this position forward your cover letter/resume/salary requirements to FMI Medical Systems, Inc.,
526 S. Main St., Suite 812, Akron, OH 44311 Attention: Human Resources,
email to FMI.Humanresources@fmimaging.com or fax to 330-253-0201

Mechanical Engineering Technician

DATE – 2/6/2012

JOB TITLE - Mechanical Engineering Technician DEPARTMENT – Engineering

ORGANIZATION DESCRIPTION – If you possess an entrepreneurial spirit and are a self-starter we will provide an exciting working environment in a highly innovative and motivated team environment! FMI Technologies Inc. is a startup international company designing and manufacturing new medical devices for use in the US and Chinese markets.

DUTIES & RESPONSIBILITIES
• Machine prototype and pre-production mechanical components
• Mechanical assembly of prototype and preproduction systems
• Assist mechanical engineers with design review producing drawings
• Set up & operate test equipment to perform in-process & final testing on parts, assemblies, or systems under simulated or actual operating conditions, & record results.
• Track & order supplies/materials.
• Collaborate with engineers and other personnel to identify, define, and solve problems.
• Continually improve manufacturing processes & procedures.
• Understand & follow all relevant regulatory agency requirements, follow all safety guidelines & report unsafe conditions to supervisor.
• Maintain a clean & safe work area.

SKILLS
• Setup, use & maintain manual machine tools (Mill, Lath, grinders, welding)
• Read mechanical drawings & work instructions
• 3D modeling and drawing (SolidWorks Preferred)
• Understand principles & theories of mechanics, materials, mechanical testing basic engineering mathematics, & knowledge of physics, electronics, & electrical circuitry helpful.
• Inspection tools including calipers, micrometers, microscopes & optical comparison.
• Fluent in English; ability to read and write Chinese (Mandarin) is an asset.
• Experience with QSR/FDA ISO 13485:2003 or other highly regulated assembly/test environment is an asset.
• Ability to effectively manage time & complete all tasks as assigned by supervisor.
• Effectively use basic office applications such as MS Word & MS Excel.
• Above all the candidate must be fair, ethical & possess a high degree of integrity.

EDUCATION – Associate (two-year technical) degree, a diploma from a technical or vocational school or equivalent military training or equivalent combination of education & experience in mechanical design & manufacturing.

EXPERIENCE – Minimum 2 year machining and/or manufacturing

TOOLS/EQUIPMENT USED – Solid Works, Machine tools, inspection equipment

To apply for this position forward your cover letter/resume/salary requirements to FMI Medical Systems, Inc.,
526 S. Main St., Suite 812, Akron, OH 44311 Attention: Human Resources,
email to FMI.Humanresources@fmimaging.com or fax to 330-253-0201

Manufacturing Mechanical Engineer

DATE – 2/6/12

JOB TITLE – Manufacturing Mechanical Engineer DEPARTMENT – Engineering

ORGANIZATION DESCRIPTION – If you possess an entrepreneurial spirit and are a self-starter we will provide an exciting working environment in a highly innovative and motivated team environment! FMI Technologies Inc. is a startup international company designing and manufacturing new medical devices for use in the US and Chinese markets.

DUTIES & RESPONSIBILITIES –
• Assist Mechanical Engineers with DFM & inspection procedures of prototype, pre-production & production parts
• Identify & evaluate machine shops
• Machine & assemble prototype & pre-production mechanical components & systems.
• Set-up, operate, & maintain manual & automated manufacturing tools & inspection equipment (Mill, Lathe, grinders, welding equipment, etc.)
• Set up & operate inspection equipment perform in-process & final testing on parts, assemblies, or systems under simulated or actual operating conditions, & record results.
• Collaborate with mechanical & electrical engineers and other personnel to identify, define, and solve problems.
• Continually improve manufacturing processes & procedures.
• Understand & follow all relevant regulatory agency requirements, follow all safety guidelines & report unsafe conditions to supervisor.
• Tack and order shop supplies
• Maintain a clean & safe work area.

SKILLS –
• Read mechanical drawings and work instructions
• Understand DFM, sustainability, & vertically integrated manufacturing.
• Understand inspection tools & statistical variation
• 3D modeling & drawing (SolidWorks Preferred)
• Understand principles & theories of mechanics, electronics, electrical circuitry, basic engineering mathematics, mechanical & materials testing, & physics.
• Fluent in English; ability to read & write Chinese (Mandarin) is an asset.
• Experience with QSR/FDA ISO 13485:2003 or other highly regulated assembly/test environment is an asset.
• Ability to effectively manage time & complete all tasks as assigned by supervisor.
• Effectively use basic office applications such as MS Word & MS Excel.
• Above all the candidate must be fair, ethical & possess a high degree of integrity.

EDUCATION – BS Mechanical or Manufacturing Engineering/Engineering Technology, or Associates (two-year) degree in combination with 5+ years of experience in machining & manufacturing.

EXPERIENCE – Minimum 2 year machining and/or manufacturing

TOOLS/EQUIPMENT USED – SolidWorks, SmarTeam, pc/MRP, Machine tools, Inspection equipment

To apply for this position forward your cover letter/resume/salary requirements to FMI Medical Systems, Inc.,
526 S. Main St., Suite 812, Akron, OH 44311 Attention: Human Resources,
email to FMI.Humanresources@fmimaging.com or fax to 330-253-0201

Quality and Regulatory Engineer

DATE – 2/6/2012

ORGANIZATION DESCRIPTION – If you possess an entrepreneurial spirit and are a self-starter we will provide an exciting working environment in a highly innovative and motivated team environment! FMI Technologies Inc. is a startup international company designing and manufacturing new medical devices for use in the US and Chinese markets.

JOB TITLE – Quality and Regulatory Engineer

DUTIES & RESPONSIBILITIES -
• Assist Quality Director in establishing, implementing and maintaining the Quality Management System that is compliant to domestic (FDA) and international (MDD, SFDA) requirements.
• Assist in practical application of ISO 13485 and 21 CFR 820.30 to product development.
• Develop training to build general quality awareness and to train on specific procedures.
• Participate in product design reviews to ensure compliance to procedures.
• Interface with Engineering and Manufacturing to ensure that transfer of new products are in accordance with approved data and regulatory requirements.
• Support manufacturing to ensure that products and processes comply with the relevant requirements of the Quality Management System.
• Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
• Analyze failure, corrective and preventive action to respond to customer complaints.
• Root cause analysis and implementation of corrective action for process related concerns.
• Responsible for planning, organizing and managing the overall activities of receiving / outgoing quality functions.
• Ensure timely supplier audits and resolution of supplier failure, corrective actions and preventive actions.
• Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
• Preparation of QA reports.

SKILLS & EXPERIENCE –
• Minimum 5 years experience in Quality Assurance and/or Regulatory Affairs in a Medical Device company
• Good communication and interpersonal skills
• Must be able to communicate fluently in both written and spoken English
• ASQ certifications are a plus
• Thorough knowledge of S.P.C techniques
• Thorough knowledge of ISO13485, 21 CFR 820
• Experience with FMEA, ISO14971, CCC and/or SFDA requirements a plus
• Thorough knowledge of product submission procedures for regulatory compliance
• Basic knowledge of P.C.’s and relevant software

EDUCATION – University degree in Industrial/Mechanical/Electrical Engineering or equivalent

To apply for this position forward your cover letter/resume/salary requirements to FMI Medical Systems, Inc.,
526 S. Main St., Suite 812, Akron, OH 44311 Attention: Human Resources,
email to FMI.Humanresources@fmimaging.com