Senior Manufacturing Lead - Temecula, CA

Info-Ways; Temecula (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer is seeking a Senior Manufacturing Lead in Temecula, CA. This role involves overseeing manufacturing processes for disposable cardio-vascular products, ensuring adherence to quality standards, and driving continuous improvement initiatives. The ideal candidate will have significant experience in medical device manufacturing, Six Sigma certification, and a strong background in process validation and improvements. Join our team to impact patients' lives positively while working within a collaborative environment.

Qualifications

• Minimum of 5 years experience in manufacturing, specifically in medical devices.
• Proven expertise in process validation methodologies.
• Strong understanding of process improvement techniques including Lean and Six Sigma.

Responsibilities

• Lead manufacturing efforts for cardio-vascular products to ensure quality and efficiency.
• Translate CTQs into actionable manufacturing specifications.
• Improving yield and product quality through ongoing assessments and process improvements.

Skills

Manufacturing experience in Medical Devices

Six Sigma certification (Black Belt)

CTQs assessment

Design and develop manufacturing processes

Process Validation (IQ, OQ, PQ)

Lean manufacturing principles

Statistical analysis and Minitab

Job description

Senior Manufacturing Lead - Temecula, CA

Role: Senior Manufacturing Lead
Location: Temecula, CA
Duration: 6+ Months
BGV will be done for the selected candidates.

Requirements

• Manufacturing experience in Medical Devices, especially disposable Cardio‑Vascular products.
• Six Sigma certified (Black Belt).
• Experience in CTQs assessment and translating CTQ into manufacturing specifications.
• Experience in performing gap assessments between design outputs and manufacturing specifications.
• Design and develop manufacturing processes, tooling, and fixtures in order to meet production needs, while enhancing productivity and product quality.
• Process Validation – Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ).
• Experience in performing process characterization studies / Design of Experiments (DOE) to establish the process window / range for all influencing process parameters.
• Experience in Test Method Validation (TMV) & Inspection Method Validation (IMV).
• Utilization of tools like Gage R&R, Cp, Cpk, and Statistical Process Control (SPC) to improve manufacturing processes.
• Good experience in Lean manufacturing. Understanding of manufacturing concepts such as Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
• Experience in Manufacturing process improvements / Yield improvements to improve product quality.
• Good knowledge in Statistics & Minitab.
• Experience in Product Risk Management as per ISO14971 with good knowledge in executing PFMEA.
• Experience in handling CAPA (including field failure / root cause investigation), SCAR and NCMRs.

All your information will be kept confidential according to EEO guidelines.