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Fmea Engineer Jobs in Minnesota (NOW HIRING)

... FMEA and Hazard Analysis in conjunction with other engineering departments. • Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final ...

Support risk management activities including FMEA and fault-tree analysis. * Partner with suppliers ... Mentor junior engineers and provide technical leadership across project teams. What We're Looking ...

Perform design analysis and FMEA's on new tools to assure form, fit, function, and safety ... Represent the Design Engineering Team with professionalism and integrity when communicating with ...

Engineer I, Manufacturing Engineering Entegris is growing and seeking an entry-level Manufacturing ... Support New Product Introduction (NPI) through FMEA facilitation, control plan development ...

... FMEA and Hazard Analysis in conjunction with other engineering departments. Provide direction in ... implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product ...

Champion reliability improvement initiatives, including RCFA, FMEA, work management best practices, and improved KPI utilization. * Collaborate closely with operations, engineering, procurement, and ...

Electrical Reliability Engineer

Cloquet, MN · On-site

$97K - $123K/yr

Champion reliability improvement initiatives, including RCFA, FMEA, work management best practices, and improved KPI utilization. * Collaborate closely with operations, engineering, procurement, and ...

Engineer I, Manufacturing Engineering Entegris is growing and seeking an entry-level Manufacturing ... Support New Product Introduction (NPI) through FMEA facilitation, control plan development ...

Senior Quality Engineer

Minneapolis, MN · On-site

$110K - $135K/yr

Collaborate with R&D, engineering, commercial, and quality teams to support FMEA activities, failure analysis, root cause investigations, CAPA implementation, and development of control plans and ...

Collaborate with R&D, engineering, commercial, and quality teams to support FMEA activities, failure analysis, root cause investigations, CAPA implementation, and development of control plans and ...

Reliability Engineer Co-op

Cloquet, MN · On-site

$97K - $123K/yr

... Analysis (FMEA), and work management enhancements. * Partner with operations, engineering ... procurement, and maintenance teams to gain exposure to cross-functional problem-solving. * Support ...

Design Engineer

Wyoming, MN · On-site

$45 - $80/hr

Experience with FMEA and dimensional tolerance stack-up analysis * Ability to perform root cause analysis and corrective actions * Experience collaborating with cross-functional engineering teams

Senior Quality Engineer

Jackson, MN · On-site

$83K - $113K/yr

The Senior Quality Engineer is responsible to ensure the operations adherence to organization ... Work with NPD in developing risk analysis documentation - FMEA, Control Plan, and support test ...

Supplier Quality Engineer

Anoka, MN · On-site

$65K - $85K/yr

RFA Engineering (www.rfamec.com) is an engineering service provider dedicated to delivering our ... Conduct design/process/assembly reviews, supplier FMEA reviews and PPAP approvals for outsourced ...

Production Engineer II

Chaska, MN · On-site

$87K - $115K/yr

The Production Engineer is primarily responsible for the technical management, maintenance and ... Create, maintain, and improve FMEA, Control Plans, and other process control tools * Identify and ...

Production Engineer II

Chaska, MN · On-site

$87K - $115K/yr

The Production Engineer is primarily responsible for the technical management, maintenance and ... Create, maintain, and improve FMEA, Control Plans, and other process control tools * Identify and ...

Senior Quality Engineer

Jackson, MN · On-site

$85 - $105/hr

Work with NPD in developing risk analysis documentation - FMEA, Control Plan, and support test ... Bachelor's degree in Engineering required. Advance degree preferred. * Sound knowledge of, and ...

Showing results 21-40

Fmea Engineer information

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.

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.

Design Assurance Engineer

Stereotaxis

Minneapolis, MN • On-site

Full-time

Re-posted 17 days ago


Job description

Shift Type
Job Title
Design Assurance Engineer
Education
Bachelor's Degree
Location
Minneapolis, MN 55401 US (Primary)
Career Level
Experienced (Non-Manager)
Category
Engineering
Date Needed By
Job Type
Full-time
Travel
Job Description
Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis' systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.

Position Summary:
The Design Assurance Engineer directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product.

Essential Responsibilities:
• Manage deliverables from the design process including DHF and Engineering Project File documents.
• Collaborate with design engineers and technicians in the development of verification/validation protocols.
• Participate on design teams to assure product requirements as well as quality requirements are documented and addressed.
• Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
• Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
• Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
• Lead the development of quality plan specific to each project.
• Assist with the development of inspection processes and equipment including test fixtures.
• Train company employees on Quality related activities.
• Other duties as assigned.

Job Requirements
Qualifications & Skills:
• Bachelor's Degree/Technical Degree in Engineering.
• Minimum 5 years medical device experience in manufacturing/quality/product development; catheter manufacturing and development preferred.
• Working knowledge of FDA/cGMP and MDD regulations/guidelines, and International Standards.
• Experience with design verifications/validations.
• Experience with all aspects of Risk Management throughout the lifecycle.
• Experience with Quality Management System software.
• Must possess good project management skills and initiative in taking on and completing projects.
• Strong verbal and written communication skills.
• Must be able to manage and prioritize multiple projects/objectives.
• Legally authorized to work in the United States

Work Conditions:
This role is an in-office position at Stereotaxis' Rogers MN facility.

Culture:
Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.

Hiring Manager
Exemption Type
# of Hires Needed
1
Wage Amount