About The Position

The Manufacturing Engineer Co-op will gain valuable knowledge pertaining to policies, practices, and processes associated with the production of Medical Devices through completion of web-based and instructor-led training. This role offers hands-on experience with primary machining processes including CNC milling, CNC turning, and forming of titanium, stainless steel, and polymer implants. The co-op will also gain experience with the design of tooling, work holding, and job aids, and will be exposed to and participate in Quality and Compliance related activities, including Non-conformance investigation and Corrective and Preventative Action (CAPA). Additionally, the co-op will assist in failure mode analysis, scrap analysis, and trending, and gain exposure to concepts of GMP/GXP as well as an introduction to FDA, ISO, Safety, and Environmental regulations. The role involves acting as a team member supporting capital investment projects and transformations, conducting research, data collection, and technical report generation, performing financial analysis, generating business cases, and conducting presentations. The co-op will also perform CAD modeling and drafting activities for 3D printed and machined manufacturing tools/fixturing, equipment layouts, and process documentation, and support the development of new processes and equipment associated with product launches. Coordination and support of equipment and process validation lifecycle elements such as computer system validation, safety risk assessment, installation qualification, process risk assessment, operation qualification, and performance qualification are also key responsibilities. The co-op will author equipment and process standard operating procedures, test protocols, and technical report documents, perform data collection and analysis utilizing statistical methods and software packages such as MS Excel and Minitab, and participate on cross-functional teams focusing on the improvement of existing processes. Support for cycle time analysis, process/value stream mapping, and capacity analysis on production processes to optimize and/or introduce new equipment, as well as assistance with testing and analysis utilizing Lean/6 Sigma tools and techniques, and completion of Kaizen implementation for ideas submitted for improvements are expected. The co-op will communicate with internal and external suppliers on various projects and initiatives, and participate in plant and product familiarization through a combination of independent research, online training, and “Go-See” activities. Finally, the co-op will participate in shadowing of various roles including Manufacturing Engineers, Quality Engineers, Engineering Technicians, and Production Operators, and will also “Go-See” groups including Chemical Finishing, Packaging, QA Inspection, Drafting, Document Control, Safety, Maintenance, Tool Room, Gage Calibration, and Shipping/Receiving.

Requirements

  • Candidates must be legally authorized to work in the U.S. and must not require sponsorship for employment visa status now or in the future (e.g. H1-B status).
  • A minimum GPA of 3.0 Cumulative is strongly preferred.
  • Candidate must be actively enrolled pursuing either a Bachelors or Master’s degree (but not necessarily taking classes).
  • Candidate must have reliable transportation to and from work on a daily basis for the duration of the co-op.
  • Candidate must be able to work full time (40 hours per week) during the duration of the co-op position.
  • Completion of sophomore level coursework strongly preferred.
  • Highly motivated self-starter able to function as part of a team and independently.
  • Possess some past hands-on experience (job, project or hobby related) strongly preferred.
  • Willing to work in a fast paced manufacturing environment with work station located on manufacturing floor.
  • Strong technical writing skills and ability to generate technical documents semi-independently.
  • Ability to present and communicate effectively to audiences at various levels of experience.
  • Efficiency with MS Word, Excel and PowerPoint.
  • Experience with some CAD package (PTC Creo, SolidWorks, AutoCAD, Inventor, etc.)
  • Introductory experience with GD&T preferred but not required.
  • Introductory experience with statistical analysis using Minitab, Excel, etc. preferred.
  • Preferred majors are, but are not limited to: Industrial, Mechanical and Manufacturing Engineering (preferred); Biomedical Engineering (considered); Engineering and Management (considered); Controls and Robotics Engineering (considered); Electrical and Chemical Engineering (considered); Additional Engineering disciplines considered on case by case basis as well.

Nice To Haves

  • Experience with MS Project, Visio, Access preferred but not required.
  • Introductory experience with GD&T preferred but not required.
  • Introductory experience with statistical analysis using Minitab, Excel, etc. preferred.

Responsibilities

  • Gain valuable knowledge pertaining to policies, practices and processes, associated with production of Medical Devices, through completion of web based and instructor led training.
  • Gain experience with primary machining processing including CNC milling, CNC turning and forming of titanium, stainless steel and polymer implants.
  • Gain experience with design of tooling, work holding and job aids.
  • Gain exposure and participate in Quality and Compliance related activities including Non-conformance investigation and Corrective and Preventative Action (CAPA).
  • Assist in failure mode analysis, scrap analysis and trending.
  • Gain exposure to concepts of GMP/GXP as well as introduction to FDA, ISO, Safety, and Environmental regulations.
  • Act as team member supporting capital investment projects and transformations.
  • Conduct research, data collection, and technical report generation.
  • Perform financial analysis, generate business cases and conduct presentations.
  • Perform CAD modeling and drafting activities for 3D printed and machined manufacturing tools/fixturing, equipment layouts and process documentation.
  • Support development of new processes and equipment associated with product launches.
  • Coordinate and support equipment and process validation lifecycle elements such as computer system validation, safety risk assessment, installation qualification, process risk assessment, operation qualification and performance qualification.
  • Author equipment and process standard operating procedures.
  • Author test protocols and technical report documents.
  • Perform data collection and analysis utilizing statistical methods and software packages such as MS Excel and Minitab.
  • Participate on cross-functional teams focusing on the improvement of existing processes.
  • Support cycle time analysis, process/value stream mapping, and capacity analysis on production processes to optimize and/or introduce new equipment.
  • Assist with testing and analysis utilizing Lean/6 Sigma tools techniques.
  • Complete Kaizen implementation for ideas submitted for improvements.
  • Communicate with internal and external suppliers on various projects and initiatives.
  • Participate in plant and product familiarization though a combination of independent research, online training and “Go-See” activities.
  • Participate in shadowing of various roles including Manufacturing Engineers, Quality Engineers, Engineering Technicians and Production Operators. Co-ops will also “Go-See” groups including Chemical Finishing, Packaging, QA Inspection, Drafting, Document Control, Safety, Maintenance, Tool Room, Gage Calibration and Shipping/Receiving.

Benefits

  • medical, dental, and vision insurance plans
  • 401(k) retirement plan
  • employee stock purchase plan
  • paid time off
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