Senior Manufacturing Engineer

Role Summary

The Senior Manufacturing Engineer supports design transfer and validation of manufacturing processes with a strong focus on endotoxin control, sterilization, and microbiology for medical devices. This role serves as the voice of operations, leading cross‑functional projects to ensure compliant, robust, and efficient manufacturing processes.

• Lead generation and execution of validation activities (IQ/OQ/PQ) and final reports, with emphasis on sterilization and microbiology.
• Support design transfer and ensure processes meet endotoxin and regulatory requirements.
• Develop master validation plans, protocols, reports, and technical documentation.
• Perform statistical analysis to support validation and quality reports.
• Manage change controls, ECOs, non-conformances, deviations, and CAPAs.
• Develop statistically based sampling plans for in‑process and final inspections.
• Troubleshoot and improve equipment and processes during validation runs.
• Collaborate cross‑functionally with Manufacturing, Quality, Regulatory, Facilities, Microbiology, and Product Development.
• Support regulatory submissions and participate in audits (FDA, ISO, Notified Body, Corporate).
• Lead or support project management activities across internal and external teams.

• BS in Engineering (Mechanical, Industrial, Electrical, Chemical, Biomedical) or related science; PE a plus.
• 7+ years of experience in medical device and/or pharmaceutical manufacturing.
• Strong knowledge of FDA, ISO, GMP, OSHA, and EPA requirements.
• Hands‑on experience with equipment and process validation.
• Proven experience with risk management, CAPA, and change control systems.
• Strong project management and cross‑functional leadership skills.
• Lean/Six Sigma Green or Black Belt preferred.

Mid‑Senior level

Contract

Medical Equipment Manufacturing