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Fmea 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 ... Lead Master Validation Plan, risk assessments (FMEA), and ensure alignment with regulatory ...

Quality Engineer

Attica, IN

$61K - $78K/yr

Root Cause and Corrective Action (RCCA), Process Mapping, Failure Mode & Effects Analysis (FMEA ... Areas of Focus The Quality Engineer is responsible for development and implementation of product ...

Develops/maintains equipment FMEA's to ensure that critical failure modes are identified and ... Ensure that the spare parts meet the engineering standards, updating engineering standards as ...

Quality Engineer II

Warsaw, IN · On-site

$69K - $89K/yr

... FMEA, and product testing methods, and ability to use general measuring equipment within production ... S. in engineering or an alternative Bachelor's degree program with certification as a quality ...

Sr. Quality Engineer

Elkhart, IN · On-site

$80K - $85K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability ... Familiarity with lean and Six Sigma, and related tools including SPC, FMEA, A3, Fishbone diagram ...

Sr. Quality Engineer

Elkhart, IN · On-site

$80K - $85K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability ... FMEA, A3, Fishbone diagram (8M, 5 Why)Familiarity with CAD software, such as Catia, SolidWorks, etc.

Sr. Quality Engineer

Elkhart, IN · On-site

$85K - $115K/yr

The Sr. Quality Engineer plays a key role in ensuring the highest standards of quality, reliability ... Familiarity with lean and Six Sigma, and related tools including SPC, FMEA, A3, Fishbone diagram ...

Engineer, Quality (CDT)

Attica, IN · On-site

$61K - $78K/yr

Root Cause and Corrective Action (RCCA), Process Mapping, Failure Mode & Effects Analysis (FMEA ... Areas of Focus Quality Engineer is responsible for development and implementation of product and ...

Quality Engineer

Attica, IN · On-site

$61K - $78K/yr

Root Cause and Corrective Action (RCCA), Process Mapping, Failure Mode & Effects Analysis (FMEA ... Areas of Focus The Quality Engineer is responsible for development and implementation of product ...

Engineer, Process City: Noblesville Country/Region: United States State: Indiana Business Area ... Write, Review, and Execute PVP, IQ, OQ, PQ, FMEA, and RA documents and summaries. Familiarity with ...

Resident Engineer

Kokomo, IN · On-site

$86K - $110K/yr

The Resident Engineer will report to the Resident Engineering Lead at the plant. The Resident ... FMEA's and associated Control Plans. * Control plan ownership and maintenance * Employ advanced ...

Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

... FMEA, and product testing methods. o B.S. in engineering or an alternative Bachelor's degree program with certification as a quality engineer (e.g. CQE). o Certified Quality Engineer (CQE) and ...

Sr. Quality Engineer

Attica, IN

$75K - $101K/yr

Root Cause and Corrective Action (RCCA), Process Mapping, Failure Mode & Effects Analysis (FMEA ... Areas of Focus The Sr. Quality Engineer is responsible for development and implementation of ...

Ensure that the product is being manufactured to all engineering/customer and manufacturing ... Training in SPC, FMEA, DOE, PFMEA, DDI, GD&T, APQP. Computer skills in the areas of databases ...

Resident Engineer

Indianapolis, IN · On-site

$86K - $110K/yr

... FMEA's and associated control plans * Provides supervision necessary to perform, administer or ... engineering standards Our Benefits - Designed with You in Mind Comprehensive Health & Well-being ...

Resident Engineer

South Bend, IN · On-site

$97K - $124K/yr

... FMEA's and associated control plans * Provides supervision necessary to perform, administer or ... engineering standards Our Benefits - Designed with You in Mind Comprehensive Health & Well-being ...

Showing results 41-60

Fmea Engineer information

How does an FMEA engineer typically collaborate with cross-functional teams during the risk assessment process?

As an FMEA Engineer, you will work closely with teams from design, manufacturing, quality, and sometimes suppliers to systematically identify and evaluate potential failure modes in products or processes. Effective collaboration is essential, as you’ll facilitate FMEA sessions, gather input from subject matter experts, and ensure that all relevant perspectives are considered. This teamwork helps to create robust mitigation strategies and action plans, making communication and coordination core parts of your daily responsibilities.

What are the key skills and qualifications needed to thrive as an FMEA engineer, and why are they important?

To thrive as an FMEA Engineer, you need a strong background in engineering principles, risk analysis, and quality management, often supported by a relevant engineering degree and experience in process improvement. Familiarity with technical tools like FMEA software (such as APIS IQ-FMEA or PTC Windchill), statistical analysis programs, and quality standards like ISO 9001 or IATF 16949 is typically required. Excellent attention to detail, analytical thinking, and strong communication skills help you collaborate effectively with cross-functional teams and present findings clearly. These skills and qualifications are essential for proactively identifying and mitigating risks, ensuring product reliability, and maintaining high quality standards in manufacturing or design processes.

What is the difference between Fmea Engineer vs Quality Engineer?

AspectFmea EngineerQuality Engineer
CertificationsISO 13485, Six Sigma, ASQ certificationsISO 9001, Six Sigma, ASQ certifications
Work EnvironmentManufacturing, automotive, aerospaceManufacturing, software, healthcare
Primary FocusFailure Mode and Effects Analysis (FMEA)Overall quality management and process improvement

Fmea Engineers specialize in conducting FMEA to identify potential failures and improve product reliability, often working closely with design and manufacturing teams. Quality Engineers have a broader role in overseeing quality systems, audits, and continuous improvement initiatives. While both roles require similar certifications and often operate within manufacturing industries, Fmea Engineers focus specifically on failure analysis, whereas Quality Engineers manage overall quality assurance processes.

What is an FMEA engineer?

An FMEA Engineer is a professional who specializes in conducting Failure Mode and Effects Analysis (FMEA) within manufacturing, engineering, or product design teams. Their main responsibility is to systematically evaluate processes or products to identify potential failure modes, assess their impact, and prioritize corrective actions to mitigate risks. FMEA Engineers work closely with cross-functional teams to improve reliability, safety, and quality standards by proactively addressing weaknesses before issues arise. Their work is crucial in industries such as automotive, aerospace, electronics, and healthcare, where product safety and reliability are critical.
What cities in Indiana are hiring for Fmea Engineer jobs? Cities in Indiana with the most Fmea Engineer job openings:
Infographic showing various Fmea Engineer job openings in Indiana as of August 2026, with employment types broken down into 92% Full Time, and 8% Contract. Highlights an 97% In-person, and 3% Remote job distribution.

Manufacturing Engineer with CNC

Noblesoft Technologies

Warsaw, IN • On-site

$70K - $89K/yr

Contractor

Re-posted 17 days ago


Job description

    
Title: Manufacturing Engineer with CNC
Location: Warsaw, IN
 
JD as below

 
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.