Manufacturing Engineer

Fluxergy; Irvine (CA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental

Work-Life Balance

Career Growth

Job summary

Fluxergy in Irvine, CA seeks a Manufacturing Engineer to optimize processes, improve production performance, and support new product introductions in a regulated medical device setting.

You will collaborate with Production, Quality, Maintenance, Supply Chain, and Engineering to drive continuous improvement, enhance product quality, efficiency, and scalability while applying Lean and Six Sigma methodologies.

Qualifications

• Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related field.
• 1+ years of manufacturing engineering experience in a regulated manufacturing environment.
• Experience optimizing manufacturing processes and supporting production operations.
• Working knowledge of Lean Manufacturing, Six Sigma, SPC, process validation, and root cause analysis.

Responsibilities

• Monitor production performance by analyzing metrics such as yield, throughput, scrap, and OEE to identify improvement opportunities.
• Troubleshoot manufacturing issues related to equipment, processes, materials, and product quality using structured root cause analysis.
• Develop, implement, and optimize manufacturing processes, workflows, tooling, and process controls to improve safety, quality, and efficiency.
• Lead Lean Manufacturing and continuous improvement initiatives to reduce waste, improve productivity, and optimize manufacturing performance.
• Support New Product Introduction (NPI), process validation, and production readiness activities.
• Create and maintain manufacturing documentation, including work instructions, SOPs, and process specifications.
• Partner with Quality to support CAPAs, process capability studies, and regulatory compliance.
• Identify opportunities for automation and manufacturing technology improvements.
• Train production personnel on new processes, equipment, and best practices.
• Collaborate cross-functional to achieve manufacturing and business objectives.

Skills

Lean Manufacturing

Six Sigma

SPC

Root Cause Analysis

Data Analysis

Project Management

Communication

Education

Bachelors in Engineering

Tools

SolidWorks CAD

JMP

Job description

About Us

Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system.

Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.

At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours.

About the Role

We're seeking a collaborative Manufacturing Engineer to optimize manufacturing processes, improve production performance, and support the successful introduction of new products. In this role, you'll partner closely with Production, Quality, Maintenance, Supply Chain, and Engineering to solve manufacturing challenges, drive continuous improvement, and enhance product quality, efficiency, and scalability. This is an excellent opportunity for an engineer who enjoys combining hands‑on problem solving with data-driven decision making in a fast-paced, regulated manufacturing environment.

Team Culture

• Collaborative


• Hands‑on


• Self‑starters


• Eager to learn


• Adaptable


• Innovative

What You Will Do

• Monitor production performance by analyzing metrics such as yield, throughput, scrap, and OEE to identify improvement opportunities.


• Troubleshoot manufacturing issues related to equipment, processes, materials, and product quality using structured root cause analysis.


• Develop, implement, and optimize manufacturing processes, workflows, tooling, and process controls to improve safety, quality, and efficiency.


• Lead Lean Manufacturing and continuous improvement initiatives to reduce waste, improve productivity, and optimize manufacturing performance.


• Support New Product Introduction (NPI), process validation, and production readiness activities.


• Create and maintain manufacturing documentation, including work instructions, SOPs, and process specifications.


• Partner with Quality to support CAPAs, process capability studies, and regulatory compliance.


• Identify opportunities for automation and manufacturing technology improvements.


• Train production personnel on new processes, equipment, and best practices.


• Collaborate cross‑functionally to achieve manufacturing and business objectives.

What You'll Need to Have

• Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or a related technical field.


• 1+ years of manufacturing engineering experience in a regulated manufacturing environment.


• Experience optimizing manufacturing processes and supporting production operations.


• Working knowledge of Lean Manufacturing, Six Sigma, SPC, process validation, and root cause analysis.


• Proficiency with SolidWorks CAD and data analysis tools such as JMP.


• Strong analytical, problem‑solving, and project management skills.


• Excellent communication skills with the ability to collaborate across cross‑functional teams.

Preferred Qualifications

• Experience in medical device, diagnostics, or life sciences manufacturing.


• Knowledge of FDA Quality System Regulations, ISO 13485, and quality tools such as PFMEA, DFMEA, and Control Plans.


• Six Sigma Green Belt or Black Belt certification.


• Experience supporting automation or Industry 4.0 initiatives.

Interview Process

Our interview processes may differ slightly from role‑to‑role; however, most of our interviews will follow a similar pattern:

• Recruiter Interview


• Hiring Manager interview


• On‑site Interview


• Decision

We are an early‑stage company and may change our interview process from time‑to‑time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn't presented.

Benefits

Excellent Medical/Dental Benefits

• 95% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents


• 100% dental and vision premiums paid for employee, partner, and dependents


• 100% Life Insurance premiums paid for the employee

Work - Life Balance Minded Time Off

• 15 paid vacation days


• 2‑week paid winter break


• 7 company paid holidays


• 5 paid sick days

A Work Culture Which Believes in Promoting from Within

• Wear lots of hats / accelerate your career growth!


• We are a flat organization by design – lots of visibility!


• Many of our current leaders started their career with Fluxergy!

Salary Range: $80,000 - $90,000/year

Additional Information

Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic.

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