Medical Device Process Validation Lead

Project overview

Job Summary

As a Technical Lead specializing in Manufacturing Process Planning, you will play a pivotal role in managing technology within projects and offering technical guidance to ensure successful work completion. Your expertise will be instrumental in enhancing team capabilities, ensuring process compliance, and driving the implementation of best practices, ultimately contributing to the organization’s objectives.

Key Responsibilities

Skill Requirements

Other Requirements

• Develop and execute IQ/OQ/PQ protocols for critical manufacturing processes.
• Conduct process characterization using DOE, SPC, and statistical modeling.
• Perform process capability studies (Cp/Cpk) and implement corrective actions for low‑capability processes.
• Define and maintain the Process Validation Master Plan (PVMP).
• Prepare validation protocols, reports, risk assessments, PFMEAs, and process maps.
• Support pilot‑to‑production scale‑up for new blood glucose sensor manufacturing lines.
• Optimize process parameters for yield, throughput, and quality.
• Lead root‑cause analysis and CAPA activities related to process deviations or excursions.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations.
• Support internal, external, and regulatory audits by providing process validation documentation.
• Work with Manufacturing Engineering and Operations to implement validated processes on the production floor.
• Train technicians and operators on validated processes and control plans.
• Bachelor’s degree in Biomedical, Chemical, Mechanical, Industrial, or related Engineering field.
• 3+ years of experience in process validation within a medical device, diagnostics, or biosensor environment.
• Strong knowledge of DOE, SPC, statistical tools (JMP/Minitab), and validation methodologies.
• Understanding of regulated medical device manufacturing and QMS requirements.
• Experience with blood glucose sensor processes or electrochemical sensor manufacturing.
• Six Sigma Green Belt or Black Belt certification.
• Experience with automated or semi‑automated process lines.
• Experience in the semiconductor industry for wafer production.

Project details

• Start: flexible
• Location: CA - California, US