rocky mountain orthodontics ®

Career Opportunities

RMO, Inc. (Rocky Mountain Orthodontics) is an internationally known manufacturer of orthodontic appliances headquartered in Denver, CO.  We have been in business for over 80 years.

To apply please email your resume including salary requirements to jobs@rmortho.com or fax to the HR department at 303-592-8223

 

Regulatory Affairs Engineer

GENERAL PURPOSE / SUMMARY OF POSITION:

Under direction of the VP of Eng/QA/Reg/SC, coordinates critical activities to support QMS compliance with ISO 13485, Council Directive 93/42/EEC, MDSAP, MHLW Ministerial Ordinance 169, and FDA QSR requirements.  Responsible for establishing and leading the internal audit program of the quality management system. Develops audit protocols and checklists. Lead Auditor responsibilities. Acts as a consultant in quality systems requirements.

Owns product registration activities both domestically and internationally. Maintains applicable establishment registrations and coordinates with international dealers/distributors and their associated regulatory authorities to ensure RMO’s product and market compliance.

Ensures corporate compliance to all required Federal, State, Local and International Regulations and Laws. Prepares all required documentation, application, and renewal of regulatory licenses, certificates, and permits for domestic and foreign entities.

Other Responsibilities / Duties:

  • Coordinate efforts associated with the preparation of regulatory documents or submissions, including establishment registration, product registration, and certificates to foreign governments.
  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare or maintain technical files and MDR’s as necessary to obtain and sustain product approval, registration, and licenses.
  • Lead and coordinate internal and/or external audits
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Participates in project teams as assigned and provides guidance on regulatory matters related to document requirements, regulatory submissions and maintenance.
  • Other duties as assigned.

JOB QUALIFICATIONS:

Education or Formal Training: 

  • Bachelors/Associates degree or equivalent work experience.
  • Lead Auditor training or certification.

Knowledge, Skills and Ability:

  • Excellent written and verbal communication skills required.
  • Proven ability of working in a cross functional team environment.
  • Must possess working knowledge of ISO 13485, CE, MDD standards
  • Knowledge of Federal, State, Local, and International Regulations and Laws for Medical Device Manufacturers.

Experience: 

  • Minimum of 5 years of experience in a Regulatory Affairs role in a Medical Device environment.
  • Must have prior CAPA and Internal Audit experience
  • Must have prior product registration and export compliance experience
  • Experience/knowledge of EU MDD/MDR preferred

 

Maintenance Mechanic 

GENERAL PURPOSE / SUMMARY OF POSITION:

Responsible for routine and preventative maintenance of production equipment and machinery, troubleshooting and repair of electrical, electronic, pneumatic/hydraulic and mechanical equipment. Rebuilding and overhauling equipment and machines such as molding machines, lasers, milling machines, welders, ovens, furnaces, punch presses, etc. when required.  Install or repair piping systems using proper plumbing and pipefitting techniques. Work performed in conformance with maintenance specifications and production scheduling requirements.

Other Responsibilities / Duties:

  • Follow proper procedures for safe handling and disposal of hazardous materials and waste.
  • Assist facilities in troubleshooting and repair of support utilities such as compressed air systems, vacuum systems, compressed gases systems, process cooling water, lighting, and electrical power distribution.
  • Work with equipment manufacturers and suppliers to procure repair parts and supplies.
  • When required, open buildings and start support systems and machinery for production.
  • Availability to work weekends, holidays, and non-production times to perform major repairs reducing the impact on production.
  • Assist operators in performing set-ups on production equipment and machinery when needed.

Education or Formal Training: 

High School Diploma or GED and electrical and mechanical courses required.

Knowledge, Skills and Ability:

Familiar with Microsoft Office products. Ability to operate fork truck and other material handling equipment to unload trucks, move equipment, machinery and supplies. Perform math functions with decimal and fractional numbers.  Must be able to read and work with engineering drawings and blue prints, do fabrication work, work with pneumatic/hydraulic circuits and electrical control circuits.  Understand tolerances and fits.  Required knowledge in building and electrical codes.  Must also be able to lift and handle 35 pounds.

Experience: 

Five years of work experience in a maintenance related position required.

 

Senior Desktop Support 

GENERAL PURPOSE / SUMMARY OF POSITION:

Performs all aspects of Local Area Network (LAN) administration; Telephone System Administration and maintenance.  Responsible for communications with remote installations, problem solving, usage monitoring, modem communications, network security and disaster recovery.  Responsible for maintaining the Firewalls, Active Directory, Group Policy, VPN systems, VMware environment, network printers, SAN and NAS storage arrays, Web services, SharePoint administration and AX environment.  Overall responsibility for providing terminal and personal computer installation/relocation as required; control and maintenance of personal computers and printers within the company to insure compatibility and integration with corporate strategies. Additionally, ensures the integrity of files/databases and ensures system backups meet guidelines spelled out in IS work instructions.

Other Responsibilities / Duties:

  • Establish and maintain a positive working relationship with all company departments to optimize working relationships and communications.
  • Maintain hardware registration and inventory to provide upgrades and ensure appropriate security levels are maintained. Maintain Inventory of Software Licenses versus Installs to prevent over installation and allow for future planning.
  • May be required to train others.  Any other duties assigned.

Education or Formal Training: 

This position requires an associate or higher degree in a computer-related field

Knowledge, Skills and Ability:

This position requires a thorough understanding of network procedures and operations.  The incumbent must have demonstrated skills in human relations and communications with non-technical end-users.

Experience: 

  • One to four years of experience in Network Analyst/Operation.
  • Two to five years of PC experience in configuration of PC’s and software packages.
  • One to five year of experience with wide and local networks including experience with common-carrier data networks.
  • Office 365, SharePoint Online, Windows 2003, Windows 2008, and Windows server 2012 experience is required.

 

Manufacturing Engineer 

GENERAL PURPOSE / SUMMARY OF POSITION:

Provides technical support to all Operations, Manufacturing, and Engineering departments of the company through design, modification, optimization and/or procurement of new equipment/processes, tooling, manufacturing methods and systems for a more efficient, cost effective manufacturing operation.

Designs, upgrades, and/or implements production equipment and/or processes to increase productivity, enhance quality, and achieve cost reduction.

Other Responsibilities / Duties:

  • Designs new tooling and fixtures to support process developments, improvements, and cost reductions.
  • Designs, conducts, and analyzes process experiments using statistical techniques.
  • Creates technical documentation that specifies the engineering requirements, manufacturing procedures, inspection methods, and required data records in compliance with regulatory requirements through Engineering Change Order (ECO)
  • Supports assigned manufacturing operation in the areas of processes, new product implementation, process and equipment validation, and troubleshooting methodologies.
  • Solves day-to-day production issues by troubleshooting processes and working directly with manufacturing supervisors
  • Provides necessary manufacturing planning specifications, equipment, and tooling to meet quality, cost, and schedules for the production of RMO products.
  • Selects the most appropriate manufacturing processes regarding rate/cost, repeatability, and reliability.  Must have ability to develop methods by which to manufacture intricate, precision parts in low, medium, and high quantities.
  • Assists Quality Assurance and other technical service personnel on the resolution of customer complaints.  Provides technical solutions to reported field problems.
  • Interfaces with external consultants and/or contractors in designing new or upgraded manufacturing processes or equipment.
  • Responsible for the timely and successful completion of large scale projects within budget constraints.

Education or Formal Training:

  • Bachelor’s Degree in Mechanical, Industrial or Manufacturing Engineering or equivalent experience.

Knowledge, Skills and Ability:

  • Strong mechanical aptitude
  • Process Validation (IQ/OQ/PQ) experience required.
  • PTC Pro-Engineer / Creo or other CAD experience a plus.
  • Project Management skills a plus.

Experience:

Three to five years of direct hands‑on experience in manufacturing systems and processes (medical device or regulated environment preferred) including:

  • Metal machining, forming, and stamping
  • Injection molding
  • Laser Welding
  • Brazing
  • Quality Engineering
  • Inspection and Testing Methods/Equipment
  • Process Development/Programming
  • Design for Manufacturing (DFM)

Prior experience in industrial automation is preferred.

 

Toolroom Machinist 

GENERAL PURPOSE / SUMMARY OF POSITION:

Primarily responsible for daily support Tool & Die makers and production by machining raw materials and providing general maintenance to tooling. Individual will have the opportunity to grow into a Tool & Die maker position. Assigned manufacturing tooling builds, preparation, and maintenance towards meeting all product requirements and specifications. RMO Tool & Die department builds and maintains: complex stamping dies, metal Injection molds, special fixturing, and special tools.

Key Responsibilities / Duties:

  • To manually machine components for: tooling assemblies, dies, and injection molds, fixtures from blue prints and concept.
  • Perform general maintenance of dies, fixtures, molds, specialized tooling, and toolroom equipment.
  • Interface with engineering, quality, and production personnel on related tooling developments, testing, improvements, and solutions.
  • Inspect parts with calipers, micrometers, comparator, height gage, Go/NOGO gages, review and interpret drawings for dimensions and tolerances.
  • Perform required duties as assigned.
  • Strong mechanical aptitude and detail oriented required, our production parts are small.

Education or Formal Training:

  • High School Diploma or Equivalency
  • Advanced Mathematics. Ability to count, add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to use of geometry and trigonometry.

Knowledge, Skills and Ability:

  • Must have basic knowledge of various toolroom equipment: surface grinders, milling machines, lathes, drill presses.
  • Having familiarity with of progressive and stamping dies, die processes, and maintenance is a plus.

Experience:

Must have complete set of toolmaker tools, i.e.: Micrometer, calipers, indicator, etc.

 

Manufacturing Operators  

Full-Time and Part-Time positions available with occasional overtime
Day shift and possibly swing shift (which will include a shift premium) hours are available:
Day shift (6:00 a.m. – 2:30 p.m. Monday through Friday)
Swing shift (2:20 p.m. to 10:50 p.m. Monday through Friday)

Job Responsibilities:

  • Performs all operations necessary for preparing, brazing, and inspecting bracket/base assemblies and tubes
  • Spot and weld brackets, tubes, and lingual attachments to bands
  • Performs all operations necessary for molding, trimming, and staging of brackets
  • Responsible to select, count and package parts to fill orders for inventory as well as customer orders on a daily basis
  • All work is to be performed in conformance with quality specifications and scheduling requirements

Education/Experience/Skills Required:

  • High school diploma or GED required
  • Ability to sit the majority of the day and work with very small parts using tweezers
  • Good eyesight and hand/eye coordination
  • Able to follow written and verbal instructions
  • Basic math skills
  • Good attendance is a must
  • Previous Manufacturing experience is preferred

 

RMO, Inc. is centrally located and offers a competitive salary and benefits package including medical, dental, vision, 401k with company match, PTO upon hire and free parking.

Resumes submitted without salary requirements may not be considered.