Remington Medical, Inc., a growing medical device manufacturing company has immediate openings for experience production employees on 1st and 2nd shifts. Previous soldering and/or assembly experience in a production environment required.

The production environment is clean, climate controlled and we are looking to hire employees with a good work ethic, strong commitment to quality, and ability to be successful in a team environment.

Remington provides a great small company work environment and opportunity to be part of a growth oriented company.

Remington Medical is an Equal Opportunity Employer and a Drug Free Workplace

Remington Medical, Inc., a growing medical device design and manufacturing company based in Alpharetta has an immediate opening for a Sr. Project Engineer. Great small company environment with the opportunity to play a key role in Remington's continued growth and success!

Responsibilities:

• Manage OEM projects by interfacing and coordinating between customer, purchasing, materials, production, quality, and engineering
• Manage multiple projects concurrently with competing resources and timelines
• Analyze existing equipment/processes and develop/implement/sustain continuous improvement plans
• Troubleshoot existing production requests and assist with the Product Development efforts of new products
• Write technical reports and documentation (i.e., Design History, Risk Management, Product Realization Files, Mold Verifications, Product/Process Validations)
• Update and maintain engineering drawings and documentation
• Implement new technologies and processes to expand manufacturing capabilities
• Perform engineering analysis on Remington and OEM products
• Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements

Requirements:

• BS degree in Engineering (or technical discipline)
• 5+ years related project engineering experience preferably in medical device or other FDA regulated industry
• Demonstrated ability to manage multiple concurrent projects with competing resources and timelines
• Strong knowledge of injection molding products/equipment/processes, electrical systems, mechanical and hydraulic application, and lean manufacturing
• Strong knowledge of product development practices
• Working knowledge of SolidWorks or similar 3D CAD application software and advanced skills in MS Word, MS Excel, MS PowerPoint, and MS Access
• Working knowledge of FDA and ISO 13485 requirements preferred
• Demonstrated ability to drive initiatives to desired results by getting cooperation from individuals in other departments
• Excellent communication, prioritization, and organizational skills

Remington is an Equal Opportunity Employer and a Drug Free Workplace!

Remington Medical, Inc., a growing medical device design and manufacturing company based in Alpharetta has an immediate need for an experienced Quality Engineer.

Responsibilities:

• Provide technical guidance to Quality Technicians and Inspectors.
• Development of Test Protocols and Final Reports.
• Development of the design risk assessment, coordinating input from other design team members.
• Development of the Final Design Verification Protocol and the subsequent Final Design Verification Report including an analysis of all data and a decision on design acceptability.
• Provide input into the project design input requirements and product development quality plan.
• Determination the degree of Biocompatibility testing required on a project. Coordinate the testing at an outside lab and document results.
• Develop or assist in developing test methods for the specifications listed in the DID.
• Develop test protocols and release a final report on Shelf Life Studies in support of expiration dating.
• Utilize statistical methods to ensure processes are capable/repeatable and sample plans are statistically valid (i.e., scientific sample size selection, statistical process capability data analysis, statistical process capability software such as Minitab, StatGraphics).
• Develop and document the monitoring and control program for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.
• Development of the process risk assessment, coordinating input from the Manufacturing Engineer.
• Perform Process Validation Studies to determine the acceptability of new processes or equipment.
• Design and qualify inspection and test equipment.
• Investigation and recommend disposition of nonconforming components and products.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Support Process Transfers of both OEM customers and RMI products from design to manufacturing.
• Conduct other Quality Control Projects as assigned.
• Perform DOE's and other statistical tests to support product and process optimization or determine causes of quality nonconformance. Initiate corrective actions as required.
• Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.
• Support goals of the Quality Assurance Department.
• Minimal travel is required (less than 10%).

Requirements:

• Bachelor's Degree in Engineering or Technical Sciences.
• A high level of competence in Quality Engineering including statistical techniques, control charts, sampling plans, Quality costs, design of experiments, correlation and regression, analysis of variance, probability etc.
• 5+ years experience in quality engineering including product/process validation and technical problem solving in medical device or FDA regulated industry.
• Intermediate to advanced level of proficiency with Minitab or StatGraphics software.
• Good oral and written communication skills.
• Knowledge of FDA QSR's, ISO13485, and ISO 14971
• Knowledge and Application of Six Sigma/Process Excellence Tools.

Remington Medical is an Equal Opportunity Employer and Drug Free Workplace!

Remington Medical, Inc., a growing medical device design and manufacturing company based in Alpharetta has an immediate opening for an experienced Molding Engineer.

Position Overview:

Responsible for the design of injection/insert molding processes and daily support of production requirements. Position will also review, interpret, validate, test, and incorporate customer requirements into product specifications.

Responsibilities:

• Manage multiple concurrent projects with competing resources and timelines
• Perform R&D on new projects from initial customer concept meeting through production release
• Lead continuous improvement initiatives
• Equipment design and review with in-house tool maker
• Product/equipment/process design, implementation and validation
• Write technical reports and documentation (i.e., Design History, Risk Management, Product Realization files, Mold Verifications, Product/Process Validations)
• Perform engineering analysis on OEM products
• Implement new technologies and processes to expand manufacturing capabilities
• Actively support compliance to FDA and ISO requirements
• Interface with customers and suppliers externally and interface with multiple disciplines internally

Requirements:

• BS in Mechanical Engineering or related discipline
• 5+ years injection and insert molding molding experience
• 2+ years medical device or FDA regulated industry experience
• In-depth knowledge of injection and insert molding products and processes
• Strong knowledge of engineering design principles, practices, and theories
• Working knowledge of GMP, FDA, and ISO requirements preferred
• Working knowledge of mechanical and hydraulic design principles
• Working knowledge of SolidWorks or similar 3D CAD applications

Remington Medical is an Equal Opportunity Employer!

Remington Medical, a growing medical device design and manufacturing company, has an immediate need for an experienced Injection Molding Technician with in-depth knowledge of injection molding processes, equipment, and materials.

Responsibilities:

• Setup, troubleshoot, and operate injection molding equipment
• Produce parts for production and validation studies
• Support production and engineering projects as needed
• Actively support compliance to FDA and ISO requirements
• Train production operators as needed

Requirements:

• 5+ years injection molding experience to include mold setup, troubleshooting, and maintenance
• In-depth knowledge of injection molding products and processes
• Flexibility to run production parts along with supporting engineering projects
• Strong communication and team skills

Remington Medical is an Equal Opportunity Employer and Drug Free Workplace!

Remington Medical, Inc., a growing medical device manufacturing company has an immediate opening for an experienced production supervisor for 2nd shift. Previous supervisory experience in a production and/or assembly environment required.

Responsibilities:

• Assign/allocate resources to manufacture, solder, assemble, mold, inspect, test, seal, sterilize, and box RMI and OEM products and their components
• Plans, schedules, and coordinates production activities to fulfill orders, meet inventory requirements, and deliver products on time per production schedule
• Recommend and implement process improvements to maximize productivity and throughput, reduce waste and scrap, improve quality, reduce cost, and provide safe work environment
• Ensure all direct reports are properly training and the training is documented prior to the employee performing the tasks
• Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements

Requirements:

• BS Degree of experience/education equivalency
• 3+ years of production supervisor experience, preferably in medical device or FDA regulated industry
• Working knowledge of ISO and FDA requirements
• Excellent communication, prioritization, and organizational skills
• Demonstrated ability to lead/motivate employees to meet or exceed goals for quality, efficiency, cost, and safety
• Working knowledge of MS Office application software

Remington Medical is an Equal Opportunity Employer and a Drug Free Workplace

Remington Medical, Inc., a growing medical device design and manufacturing company based in Alpharetta, has an immediate opening for an experienced Moldmaker.

Responsibilities:

• Build molds for injection and insert molding equipment
• Repair/rework molds

Requirements:

• Experience with MasterCam
• Experience with 3D milling
• Experience with Wire/Sinker EDM preferred

Remington Medical is an Equal Opportunity Employer and Drug Free Workplace!

Remington Medical, Inc., a growing medical device design and manufacturing company based in Alpharetta has an immediate opening for a Project Manager. Great small company environment with the opportunity to play a key role in Remington’s continued growth and success!

Responsibilities:

• Manage Remington and contract manufacturing projects by interfacing and coordinating between customer, purchasing, materials, production, quality, and engineering
• Manage multiple projects concurrent projects with competing resources and timelines
• Analyze existing equipment/processes and develop/implement/sustain continuous improvement plans
• Troubleshoot existing production requests and assist with the R&D efforts of new products
• Write technical reports and documentation (i.e., Design History, Risk Management, Product Realization Files, Mold Verifications, Product/Process Validations)
• Update and maintain engineering drawings and documentation
• Implement new technologies and processes to expand manufacturing capabilities
• Perform engineering analysis on Remington and OEM products
• Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements

Requirements:

• BS degree in Mechanical Engineering  (or other technical discipline)
• 5+ years related project engineering experience preferably in medical device or other FDA regulated industry
• Demonstrated ability to manage multiple concurrent projects with competing resources and timelines
• Strong knowledge of Design History Files and other required technical documentation
• Strong knowledge of phase gate product development process
• Strong knowledge of engineering principles, practices, and theories
• Working knowledge of SolidWorks or similar 3D CAD application software and advanced level skill with MS Word,  MS Excel, MS PowerPoint, and MS Access
• Working knowledge of FDA and ISO 13485 requirements preferred
• Demonstrated ability to drive initiatives to desired results by getting cooperation from individuals in other departments
• Excellent communication, prioritization, and organizational skills

Remington is an Equal Opportunity Employer and a Drug Free Workplace!