Production Engineer Jobs in Irvine, CA

About Biomerica90

At Biomerica (NASDAQ: BMRA), we improve lives by developing, manufacturing, and marketing diagnostic products that enhance health and well-being while reducing total healthcare costs. We are a growing global company that drives innovation in diagnostics in gastrointestinal and inflammatory disease diagnostics. Joining us is a chance to make a real impact on people’s lives.

The Role

The Senior Production Manager oversees our immunoassay manufacturing operations — ELISA and Lateral Flow Assay (LFA) IVD kit production — owning output, quality, continuous improvement, and regulatory compliance. You will lead a cross-functional team, bring hands-on immunoassay depth, and set the standard for operational excellence on the floor.

What You’ll Own

Production & Team Leadership

• Plan, schedule, and run daily ELISA and LFA kit production to meet demand and business goals.
• Lead, mentor, and develop supervisors, technicians, and associates; own performance reviews and growth plans.
• Set and report production KPIs (yield, throughput, cycle time, and on-time delivery) to senior leadership.
• Manage headcount, scheduling, and resources to balance labor efficiency with product quality.
• Keep training records and competency assessments current and audit-ready.

Technical Operations & Troubleshooting

• Provide hands-on technical leadership across antibody purification, biotinylation, and conjugation; ELISA plate coating; LFA membrane/conjugate spray; and kit assembly.
• Lead root cause analysis for production failures, lot rejections, and OOS results.
• Partner with R&D, Quality, and Regulatory to resolve complex issues with sustainable corrective actions.
• Champion new product introduction and design transfer into manufacturing.

Process Improvement & Validation

• Drive continuous improvement to raise process capability, cut variability, and eliminate waste (Lean/Six Sigma).
• Author, execute, and approve validation protocols (IQ/OQ/PQ) for new equipment, processes, and transfers.
• Work with Process Development and Quality Engineering on CPPs and CQAs.
• Use SPC and trend analysis to spot improvement opportunities early.

Quality & Regulatory Compliance

• Ensure compliance with 21 CFR Part 820, ISO 13485, and applicable IVD requirements (CE-IVD, IVDR as applicable).
• Author and close NCMRs, deviations, and CAPAs with rigorous root cause analysis and effectiveness verification.
• Execute the site Quality Plan; support FDA, notified body, and customer audits in a continuous state of readiness.
• Partner with QA on product release, Annual Product Reviews, and Management Review.

Inventory & Materials Management

• Oversee raw material, WIP, and finished goods inventory to protect the schedule while minimizing excess and obsolescence.
• Maintain reorder points, safety stock, and lot traceability per IVD requirements.
• Partner with Procurement to forecast needs and mitigate supply risk on critical reagents (antibodies, nitrocellulose, microtiter plates).
• Keep ERP/MRP records accurate; run cycle counts and enforce FIFO/expiry control on temperature-sensitive materials.

Qualification (Required)

• Bachelor’s degree in Biochemistry, Biology, Biomedical Engineering, Life Sciences, or related field — or equivalent experience.
• 7+ years in IVD or medical device manufacturing, including 3+ years leading people.
• Hands-on ELISA and LFA manufacturing expertise (coating, conjugate prep, formulation, membrane processing, strip/kit assembly).
• Track record managing NCMRs, deviations, and CAPAs within a regulated QMS.
• Direct experience authoring/executing IQ/OQ/PQ in an IVD or device environment.
• Working knowledge of 21 CFR Part 820 and ISO 13485.

Nice to Have (Preferred)

• Master’s or Ph.D. in a relevant field.
• Experience in immunoassay development or manufacturing including ELISA and LFA
• IVDR/CE-IVD familiarity; experience supporting FDA or notified body audits.
• Proficiency with eQMS (MasterControl, Veeva, TrackWise) and ERP/MRP systems.
• SPC/DOE and statistical software (Minitab, JMP).
• Experience with POC LFA / high-volume strip manufacturing ; multiplexed or chemiluminescence/fluorescence formats.
• Lean or Six Sigma certification (Green /Black Belt).

Physical Demands & Work Environment

This is an onsite manufacturing role. Reasonable accommodations will be made for individuals with disabilities to perform essential functions. [Confirm specifics: time standing on the floor, gowning/cleanroom, lifting limits, reagent/PPE handling.]

Compensation & Benefits

Salary range: $90,000–$120,000 annually, based on experience and qualifications. [Add benefits summary: medical/dental/vision, 401(k), PTO, etc.] Pay range is included to comply with California pay transparency law (Cal. Labor Code § 432.3).

Equal Opportunity

Biomerica is an equal opportunity employer. We celebrate diversity and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic.

This description reflects the general nature and level of work and is not an exhaustive list of duties.

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Parental leave
• Retirement plan

Work Location: In person