Senior Technical Documentation Engineer - Regulated Medical

3M HEALTHCARE; Long Beach (CA); On-site; USD 93,500 - 112,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with employer match

Paid time off

Job summary

Hydrafacial is seeking a Senior Technical Documentation Engineer in California to lead research, product development, and sustaining engineering documentation.

The role focuses on writing and coordinating documentation to meet FDA/ISO standards, including design controls and design history files. You will update procedures, generate CAD drawings with SolidWorks, and collaborate with R&D and the legal team.

Qualifications

• 5+ years of experience writing/leading documentation in a regulated environment
• Knowledge of design controls (FDA 21CFR820.30) and DHF
• Complete understanding of document control practices (ECRs, ECOs, deviations)
• BS degree in Engineering or related technical field
• MS in related technical field (desired)
• Lean Six Sigma certification (desired)
• Strong communication and presentation skills (desired)

Responsibilities

• Ensure R&D and other disciplines follow good documentation practices.
• Update existing R&D procedures and forms to align with FDA/ISO standards and internal design practices.
• Ensure R&D and other disciplines follow through on design control and key documentation.
• Manage the creation of overarching design control documentation.
• Assist in writing requirements, protocols, reports, and other key documentation, and in creating CAD drawings.
• Organize documentation captured during research and product development for patent sharing with legal.

Skills

5+ years experience in regulated docs

Design controls (FDA 21CFR820.30)

Documentation organisation and DHF

Strong communication and presentation

Education

BS degree in Engineering or related field

MS in related technical field

Tools

SolidWorks

Job description

Hydrafacial is seeking a Senior Technical Documentation Engineer in California to lead research, product development, and sustaining engineering documentation.

The role focuses on writing and coordinating documentation to meet FDA/ISO standards, including design controls and design history files. You will update procedures, generate CAD drawings with SolidWorks, and collaborate with R&D and the legal team.