Manufacturing Engineer

Date
August 14, 2026
Department
Engineering
Manages
0
Direct report(s)
Reports To
Manufacturing Engineering Manager
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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.

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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)

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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)

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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).

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