OCM (Oxygen Concentration Module) Engineer
Job Summary:
Senior or Principal level Mechanical Engineer (OCM) that supports the development of an oxygen concentrator module and assists in the integration into a current respiratory humidifier. This role shall design, develop, assemble, and test all things that pertain to this new device. The OCM Engineer shall be the subject matter expert on oxygen generation/concentration, and the technologies that surround it. They shall have the knowledge base pertaining to the compatible materials, cycle times, component selection, sieve materials, and basic electro-mechanical knowledge to support the development of such device.
Supervisory Responsibilities:
? N/A
Duties/Responsibilities:
\- Provide engineering support in the design and development of oxygen concentrator device.
-Design, develop, create, test and iterate new technologies to fulfill the needs of the organization.
\- Create design and development documents per design control processes
-Test designs to verify and validate designs to PRD and MRD documentation
\- Author test protocols and test reports with technical detail to provide objective evidence
-Analyze data and interpret findings as a technical/test report
-Develop processes for manufacturing, and implement process aids or fixtures
\- Conduct training for operators on standard work and trouble-shooting techniques, and evaluate the effectiveness of training.
\- Follow and ensure adherence to GMP&\#39;s and GDP’s.
-Adhere to all safety and good housekeeping regulations.
Required Skills/Abilities:
? Must have experience working on oxygen concentrators
? Understanding of VPSA and PSA systems
? Knowledge of zeolite materials and other molecular sieve materials
? Knowledge and hands-on experience with tools and equipment used in lab and machine shop setting.
? Must have technical aptitude
? Ability to read, write, understand, and effectively communicate job related information in English.
? Basic computer skills including Microsoft Windows, Word, and Excel, and the ability to send/receive email.
? Knowledge of company policies, procedures, cGMP&\#39;s, and OSHA regulations.
? Skilled with 3D CAD software (Solidworks preferred) and can draft technical drawings
? Knowledge of additive manufacturing technologies such as FDM 3D printing and SLA/SLS 3D
printing
? Ability to source, set-up, and validate equipment.
Preferred Skills/Abilities:
? Self-starter, with the ability to manage one’s own workload
? Experience within design controls of medical device industry
? Knowledge of MDR compliance
? Experience in 60601 standards
? Experience in designing for oxygen compatibility
? Demonstrated skills in technical areas (mechanics, electronics and electricity)
? Familiarity with manufacturing techniques and methodologies
Travel Required:
0 %
Language Skills:
Must be able to communicate effectively in English. Ability to read and interpret technical documents.
Ability to write routine reports and correspondence.
Education and Experience:
? Engineering degree in Mechanical, Biomedical, STEM, etc with a high aptitude for technical
abilities.
? Minimum 5 years previous experience in the medical device industry
? Experience with working with oxygen concentrators 2+ years
Physical Requirements:
Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like.
? Never X Occasionally ? Constantly
Moving self in different positions to accomplish tasks in various environments including tight and
confined spaces.
? Never X Occasionally ? Constantly
Remaining in a stationary position, often standing or sitting for prolonged periods.
? Never ? Occasionally X Constantly
Moving about to accomplish tasks or moving from one worksite to another.
? Never ? Occasionally X Constantly
Adjusting or moving objects up to 25 pounds in all directions.
? Never X Occasionally ? Constantly
Communicating with others to exchange information.
? Never ? Occasionally X Constantly
Repeating motions that may include the wrists, hands and/or fingers.
? Never ? Occasionally X Constantly
Operating machinery and/or power tools.
? Never ? Occasionally X Constantly
Operating motor vehicles or heavy equipment.
? Never X Occasionally ? Constantly
Assessing the accuracy, neatness and thoroughness of the work assigned.
? Never X Occasionally ? Constantly
Environmental Conditions
Low temperatures.
? Never X Occasionally ? Constantly
High temperatures.
? Never X Occasionally ? Constantly
Outdoor elements such as precipitation and wind.
? Never X Occasionally ? Constantly
Noisy environments.
? Never ? Occasionally X Constantly
Hazardous conditions.
X Never ? Occasionally ? Constantly
Poor ventilation.
? Never X Occasionally ? Constantly
Small and/or enclosed spaces.
? Never X Occasionally ? Constantly
No adverse environmental conditions expected.
X Never ? Occasionally ? Constantly
Physical Demands
Sedentary work that primarily involves sitting/standing.
? Never ? Occasionally X Constantly
Light work that includes moving objects up to 20 pounds.
? Never ? Occasionally X Constantly
Medium work that includes moving objects up to 50 pounds.
? Never X Occasionally ? Constantly
Heavy work that includes moving objects up to 100 pounds or more.
? Never X Occasionally ? Constantly
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and
responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities
required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities
to this job at any time. The duties and responsibilities in this job description may be subject to change at
any time due to reasonable accommodation or other reasons.