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FMI New Employment Opportunities

_______________________________________
PET Image Reconstruction Scientist

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
The Image Reconstruction Scientist is responsible for designing and testing of PET image reconstruction and correction algorithms for a clinical PET/CT system.

Duties including (but not limited to):
• Deliver advanced algorithms for achieving high quality PET images
• Research and develop innovative calibration and correction algorithms for the cutting-edge PET scanner
• Establish validation and verification methods for the developed algorithms
• Incorporate feedback results into algorithm design
• Collaborate with software engineers in product quality implementation
• Prepare technical documentation for internal design reviews and external presentations .

QUALIFICATIONS -
• PhD Degree in Computer Science, Electrical Engineering, Biomedical Engineering, Physics or related fields -OR- Master’s degree and 5+ years related work experience in image reconstruction is equally accepted
• Experienced in developing PET image reconstruction, calibration and correction algorithms
• Strong understanding of the physics of PET imaging

DESIRED SKILLS -
• Hands on experience in medical image quality analysis
• Experienced in C/C++ programming and MATLAB is a plus
• Knowledge of medical imaging system modeling and simulation is a plus
• Experience in GPU (CUDA) programming is a plus
• Demonstrated excellence in communication and team collaboration skills •

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

_______________________________________
PET Image Reconstruction Software Engineer

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
The Software Engineer is responsible for implementing and testing of PET image reconstruction software for a clinical PET/CT system.

Duties including (but not limited to):
• Collaborate with PET image reconstruction algorithm designers in requirements gathering, design, implementation
• Create product-level software solutions utilizing the high performance computing technologies
• Work across the entire software development lifecycle including software design, peer-review codes, implementation, verification, maintenance and documentation.
• Work closely with the entire team to integrate the reconstruction component into the system software platform
• Prepare technical documentation for internal design reviews and external presentations

QUALIFICATIONS -
• Bachelor’s Degree in Computer Science, Electrical Engineering or related fields
• 2+ years of work experience in software development
• Experience in medical image processing a strong plus
• Demonstrated excellence in communication and team collaboration skills
• Experienced in C/C++, and C# is a plus
• Experienced in GPU (CUDA) programming
• Working knowledge of fundamental software engineering tools and methodologies, including but not limited to configuration management tools, version control, automated testing
• Demonstrated strong knowledge of software development life cycle

DESIRED SKILLS -
• Experience in medical image processing a strong plus
• Demonstrated excellence in communication and team collaboration skills

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

_______________________________________
Quality/Regulatory Lead

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION – REGULATORY
• Regulatory Affairs lead for CT (Computed Tomography) and PET/CT Programs
• Assume lead role in regulatory issues related to such items as labeling and marketing ideas, preparing documents required in the Development Life Cycle, audits, and recommending strategies for most efficient and effective approvals of regulatory applications for a program.
• Directly responsible for the coordination and preparation of document packages for regulatory submissions for the US, China and emerging markets including 510(k) Pre-market Notifications, PMAs, Product Reports and Supplements.
• Work with company personnel to register facilities and products with US-FDA and China-FDA (CFDA) and maintain company compliance as needed. Keep abreast of regulations in the US, China and emerging markets.
• Keep abreast of regulations in the US, China and emerging markets.

JOB DESCRIPTION – QUALITY
• Ensuring that processes needed for the business-quality management system are maintained.
• Maintaining the Business- Quality Management System of the organization.
• Supervising the Business- Quality Management System internal auditing within the organization.
• Liaison with external parties in matters relating to the Quality/Business Management System
• Coordinates and lead Corrective and Preventative Actions (CAPA) and Vendor Corrective Action Request (VCAR) processes through mentoring and shared accountability
• Assures compliance to the external audit program and manage third party and external customer audit
• Coordinates and leads Business Systems Review/Management Reviews upon request
• Recommends and supports activities toward continuous improvement methodologies
• Work closely with functional heads on a monthly basis to provide process performance (metrics) information for Non-conforming reporting for the relevant month. Report information to responsible management designee when requested monthly.
• Participate in corrective action review board meetings. Ensure that corrective actions records are completed according established expectations.
• Business Systems Review-Work to develop an agenda for a periodic business- quality systems review. Coordinate and ensure all inputs to this review are available in an acceptable format at least one business day prior to the review date.
• Provide guidance on internal and global compliance, such as product registrations, clinical evaluations in accordance with ISO 13485 and ISO 9001 and other authorities having jurisdiction.
• Provide support to overseas Quality Assurance Department and supervise domestic quality control area.
• Support new product development with R&D and Marketing as needed.
• Work with Marketing and Operations team in artwork label review.

Additional responsibilities include:
• Defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements
• Providing information and materials for Certificate to Foreign Governments (CFG) and medical device listings for the FDA.
• Participate in external audits such as FDA, 3rd party external regulatory agencies like SFDA and notified body audits.
• Perform other reasonable responsibilities related to regulatory affairs and quality assigned by the supervisor.

QUALIFICATIONS -
• Bachelors of Science degree or Higher in a technical or business discipline.
• Minimum of 5 years of experience in a medically regulated and technical environment with at least five years in a medical device company (FDA Class I or II equivalent – Class III a plus).
•Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide.
• Experienced in design control process
• Strong working knowledge of medical device regulations (21CFR) and FDA law
• Experience in supporting international registrations desirable.

DESIRED SKILLS -
• Certified regulatory affairs professional would be desirable.
• Ability to speak Mandarin a plus.

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

_______________________________________
Technical Writer

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
Technical writer needed to develop content for installation, maintenance, operator and training manuals

QUALIFICATIONS -
• Minimum of five years technical writing experience with emphasis on electro-mechanical products or medical device manufacturing- OR – Bachelor's degree in journalism or technical writing plus two years technical writing experience with emphasis on electro-mechanical products or m3edical device manufacturing.
• Experience with technical writing and illustration tools with the ability to create multi-page documents
• Strong writing and proofreading skills
• Ability to interface with design and manufacturing engineers
• Microsoft office (including Word, Excel, and PowerPoint) experience

DESIRED SKILLS -
• Excellent organizational and planning skills, including management of multiple projects and schedules
• Identify and utilize available resources for required content (ex. BOMs, engineering drawings and schematics, graphics, etc.)
• Convert, import and format various content types into established document templates and styles
• Maintain document revision control
• Manage and adhere to project scope
• Provide project status reports
• Ability to understand technical information and to learn quickly
• Proficiency with the following:
o Adobe InDesign or other page-layout writing software (such as FrameMaker)
o Adobe Photoshop and Illustrator or other raster/vector illustration tools
o SolidWorks or other 3-D modeling/CAD software
o pc/MRP or other material requirements planning software
o Experience with SmarTeam

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

_______________________________________
Mechanical Engineering Technician

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
• Machine prototype and pre-production mechanical components
• Mechanical assembly of prototype and preproduction Computed Tomography 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.

QUALIFICATIONS -
• 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
• Minimum 2 years of experience in machining and/or manufacturing.


DESIRED 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. • Ability to use inspection tools including calipers, micrometers, microscopes & optical comparison.
• 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.
• Ability to use basic office applications such as MS Word & MS Excel

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

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.










 

 

_______________________________________
Electromechanical Assembler

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
• 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 standard and custom 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.
• 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. medical

QUALIFICATIONS -
• 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.
• Minimum of three years of experience in electro-mechanical assembly/test work.

SKILLS –
• Understand principles & theories of electronics, mechanics, optics, 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.
• 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.

PHYSICAL REQUIREMENTS –
• Must be able to walk, sit and/or stand throughout an eight or ten-hour day.
• 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 resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


 

 

_______________________________________
CT Image Reconstruction Algorithm Engineer

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
• Computerized tomography (CT) data calibration algorithm development
• Create CT image reconstruction algorithms development and performance evaluation
• Programming in C/C++, MATLAB
• Design, implement and maintain software for CT image reconstruction
• Other software development duties as required

QUALIFICATIONS -
• Doctorate degree in mathematics, physics, computer science, engineering or relevant fields with at least 3 years relevant medical imaging experience.
• CT image reconstruction Algorithm development experience.
• C++ programming skills
• Strong analytical skills.

DESIRED SKILLS -
• CT physics knowledge.
• Good mathematics and DSP knowledge.
• GPU-CUDA programming skill.

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

 

_______________________________________
CT Image Reconstruction Software Engineer

JOB LOCATION -
FMI Medical Systems, Inc.
526 South Main Street, #608C
Akron, Ohio 44311

JOB DESCRIPTION –
• Computerized tomography (CT) data calibration software development
• Design, implement and maintain software for CT image reconstruction
• GPU based parallel C/C++ Programming (CUDA)
• Other software development duties as required

QUALIFICATIONS -
• Bachelor, Master or higher degree in computer science, engineering ,mathematics, physics or relevant fields with at least 3 years software development experience.
• CT image reconstruction software development experience is a plus.
• Excellent MATLAB, C, C++ and GPU (CUDA) programming skills under Windows Visual Studio environment.
• Large scale software system development experience.
• Familiarity with full software life cycle.

DESIRED SKILLS -
• CT physics knowledge.
• Good mathematics and DSP knowledge.

 

To apply for this position forward your resume to this address:
FMI Medical Systems, Inc.
526 South Main St. #608C
Akron, OH 44311
ATTN: Human Resources
Or email to Barbara.mach@fmimaging.com

FMI is an equal employment employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

 

 

 

 
FMI Medical Systems,Inc.
526 South Main St. Suite #608C
Akron, Ohio 44311
Office (330)253-0200
FAX (330)253-0201
 

 

Last modified on September 22, 2014
Copyright © 2014 FMI Medical Systems,Inc., FMI Medical Systems, Ltd.,
All rights reserved.