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Flex Cnc Manufacturing Engineer Jobs in Indiana (NOW HIRING)

CNC MFG Engineer

Warsaw, IN · On-site

$70K - $89K/yr

Job Title: Sr CNC MFG Engineer Location: Warsaw, IN JD as below * Role: Validate CNC equipment and related processes used to manufacture medical devices. * Focus: Ensure IQ/OQ/PQ, calibration ...

CNC Manufacturing Engineer

Elkhart, IN · On-site

$69K - $88K/yr

Develop manufacturing processes and improvements within CNC machining department * Assure product ... High School Diploma, 2-year Technical/engineering degree/Tool and Die Journeyman * Minimum of 3-5 ...

CNC Manufacturing Engineer

Elkhart, IN · On-site

$69K - $88K/yr

Develop manufacturing processes and improvements within CNC machining department * Assure product ... High School Diploma, 2-year Technical/engineering degree/Tool and Die Journeyman * Minimum of 3-5 ...

This CNC Manufacturing Programmer role supports R&D-driven, low-volume jobs by developing creative ... Some flex available depending on workload --- Apply Now Want to take your CNC programming career to ...

This role supports production operations, CNC machining, process development, manufacturing planning, industrialization, and continuous improvement initiatives. The Manufacturing Engineer will ...

Provide technical support for CNC machining, including programming, machine setup, and ... Manufacturing engineering experience or process engineering experience in a production environment.

Provide technical support for CNC machining, including programming, machine setup, and ... Manufacturing engineering experience or process engineering experience in a production environment.

Manufacturing Engineer

South Bend, IN · On-site

$75K - $90K/yr

The Manufacturing Engineer will work closely with Engineering, Operations, and Quality teams to ... CNC equipment consists of horizontal milling, 5th axis milling, mill/turn and lathe styles ranging ...

CNC Machinist

Fountaintown, IN · On-site

$19.75 - $27/hr

Position Summary Flex Rock Performance is seeking an experienced CNC Machinist to manufacture precision UTV performance components from billet aluminum and other engineered materials. This role is ...

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Flex Cnc Manufacturing Engineer information

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CNC MFG Engineer

Noblesoft Technologies

Warsaw, IN • On-site

$70K - $89K/yr

Contractor

Re-posted 16 days ago


Job description

Job Title: Sr CNC MFG Engineer
Location: Warsaw, IN
 
Job Description: JD as below
 
  • Role: Validate CNC equipment and related processes used to manufacture medical devices.
  • Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment.
  • Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation.
Key Responsibilities
  • Develop and execute validation activities for CNC machines (e.g., mills, lathes, multi-axis CNCs) and associated tooling/work holding.
  • Create and maintain validation documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports.
  • Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory requirements (ISO 13485, GMP, 21 CFR Part 820).
  • Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Equipment Engineering to qualify new machines and implement change controls.
  • Design, execute, and document calibration, metrology, and gauge R&R activities; ensure traceability of measurement equipment.
  • Analyze process data (statistical methods, capability studies like Cp/Cpk, Gage R&R) to demonstrate repeatability, accuracy, and process control.
  • Generate, review, and approve validation reports; ensure closure of deviations, CAPAs, and non-conformances.
  • Support supplier qualification and acceptance tests for CNC-related components and tooling.
  • Provide training and knowledge transfer to operators and maintenance staff on validated CNC processes.
  • Ensure compliance with documentation control, record retention, and audit readiness; participate in internal/external audits.
  • Maintain equipment lifecycle documentation (maintenance plans, calibration schedules, firmware/software updates) and ensure alignment with change management processes.
  • Support manufacturing investigations and root-cause analyses related to CNC processes and equipment performance.
Required Qualifications
  • Education: Bachelor’s degree in mechanical engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
  • Experience: 3–7 years in CNC manufacturing and equipment validation in a regulated environment (MedTech, pharma, or healthcare devices).
  • Regulatory & Standards: Strong knowledge of ISO 13485, GMP, and 21 CFR Part 820; familiarity with risk management (ISO 14971) and validation concepts (IQ/OQ/PQ).
  • Technical Skills:
    • Proficiency in developing and executing IQ/OQ/PQ protocols.
    • Experience with metrology, calibration, and measurement system analysis.
    • Knowledge of CNC machines, CAM software, and basic CNC programming concepts.
    • Statistical tools experience (Minitab, JMP, or similar) for process capability studies.
    • Document control and eQMS systems experience (e.g., MasterControl, ETQ, etc.).
  • Communication: Strong written and verbal communication; ability to write clear validation documentation and present findings to cross-functional teams.