Manufacturing Engineer

Role details

Date

August 14, 2026

Department

Engineering

Manages

0

Direct report(s)

Reports To

Manufacturing Engineering Manager

Job Details ---------------

Summary

The Manufacturing Engineer is responsible for supporting transfer to manufacturing activities and sustaining & improving ongoing manufacturing processes. This is a key critical role in the validation & maintenance of robust processes, assembly tools & methods, manufacturing processes, etc.

This position requires 1) technical expertise in validation, process improvement & implementation activities for associated materials, components, assemblies, processes, tooling/fixtures, & equipment; 2) communicating with customers, vendors, & various project teams; 3) report preparation for project status & validation activities; 4) assisting the Engineering team with the development cost-effective & efficient processes; 5) participation on a team that ensures robust processes are ready for transfer to the Robling Medical manufacturing environment on time.

Primary Duties and Responsibilities

• Technical and hands-on leadership in following:

• MFG Line Design & Setup Leadership

• MFG Efficiencies Monitoring, Evaluation/Analysis, Improvement

• Equipment and Process Validation - Protocol Development, Execution, and Report Writing

• Root Cause Analysis in Support of CAPAs, NMRs, etc.

• Evaluation, scoping, budgeting, execution, and Reporting of process improvements and cost reductions

• Participation in the management of the company Calibration Program

• Equipment & Tooling Control Program Management

• XFER to MFG - Initial Release, Training, Line Setup, Life Cycle Support

• Assistance with Development of Manufacturing Documentation (DMR, Work Instructions, BOMs, Routers and etc.)

• Assistance with Maintenance Troubleshooting & PM Program Management

• Assistance with Process Development Activities

• Assistance with Design for Manufacturing

• Assistance with Package Development and Qualifications

• Assistance with Test Method Development and Qualification

• Assistance with Tooling & Fixture Design and Qualification

• Risk Analysis Support (pFMEA)

• Ensures manufacturing processes remain in compliance with ISO and FDA regulations.

‍

Required Qualifications

• 4-year degree in an Engineering field (Biomedical, Mechanical, Industrial or Electrical) or equivalent combination of 4-year degree & applicable experience with at least 2 years of experience in the field. Applicable internship experience may also be considered.

• DOE design and execution

• Validation protocol generation, execution, & report writing

• Experience in developing & maintaining pFMEAs

• Strong project management skills

• Excellent interpersonal skills & written communication

• Strong analytical skills & attention to detail

• Highly motivated self-sta1ier with ability to drive for results

• Demonstrate ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independently

• Experience in a fast-paced environment where 'speed to market" is identified as a key performance indicator

• Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools,CAD, Statistical Software, Graphic Design Tools)

‍

Preferred Qualifications

Experience in an ISO 9001 or ISO 13485 manufacturing environment

• Medical Device or Pharmaceutical development or manufacturing experience

• Experience with sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.

• Technical skills in manufacturing processes & methods including flow, layout, assembly & production equipment

• Cross-discipline engineering experience

• Demonstrated ability to lead & manage a team

• Experience in troubleshooting & repairing equipment

• Experience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cutting/punching/skiving/forming thermoplastics, inspection & test equipment (leak testing, scales, force gauges, etc.)

• Lean Six Sigma Green Belt Certification

• Experience with MiniTab

• Experience with SolidWorks

• Experience with electro-mechanical devices & equipment (design, fabrication/assembly, installation, qualification, operation)

‍

Environment & Working Conditions:

This position is generally performed indoors in a plant or office environment and requires specific physical requirements that must be met, including:

• Some heavy lifting and considerable moving of equipment(lifting up to 50pounds)

• Standing for long periods of time

• Sitting for long period of time

• Bending and ability to reach with hands &arms

• Visual - constant visual attention (i.e., color vision, depth perception, ability to adjust focus).