Sr. Process Development Engineer

Overview

Lead process development activities from concept through commercialization for new medical devices.

Responsibilities

• Lead process development activities from concept through commercialization for new medical devices.
• Develop and optimize manufacturing processes including tooling, fixtures, automation, and equipment validation.
• Execute process characterization, DOE, and root cause analyses using statistical tools (e.g. Minitab, JMP).
• Design and conduct engineering studies, test protocols, and reports (IQ / OQ / PQ) in support of product development and regulatory submissions.
• Collaborate closely with R&D, Quality, Regulatory, and Manufacturing teams to ensure process scalability and compliance with FDA, ISO 13485, and GMP standards.
• Define and implement process control strategies, including PFMEA, control plans, and SPC.
• Lead or support technology transfer from R&D to manufacturing, including supplier engagement and pilot builds.
• Identify and implement cost reduction and yield improvement initiatives.
• Support CAPA investigations and implement robust corrective and preventive actions.
• Stay abreast of emerging technologies and trends in medical device manufacturing and process automation.

Qualifications

Seniority level

Employment type

Job function

Industries

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