Sr Technical Documentation Engineer - Long Beach, CA

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

Job Description

The Senior Technical Documentation Engineer is responsible for research, product development, and sustaining engineering documentation.

Primary Responsibilities

• Ensure R&D and other disciplines follow good documentation practices.
• Update existing R&D procedures and forms to align with the latest standards (FDA and ISO) and internal design practices.
• Ensure R&D and other disciplines follow through on design control and other 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 that will be shared with the legal team for patents.
• Other duties as assigned.

Experience / Skills / Education

• Required:
  • BS degree in Engineering or related technical field
  • 5+ years of experience in writing and leading documentation in a regulated environment
  • Experience with SolidWorks in creating 2D drawings
  • Knowledge of design controls (FDA 21CFR820.30) and generating and maintaining design history files (DHF)
  • Complete understanding of document control practices (ECRs, ECOs, deviations, etc.)
• Desired:
  • MS in a related technical field
  • Lean Six Sigma certification
  • Strong communication and presentation skills

Base Pay

$93,500 - $112,000 + bonus. Pay is based on education, qualifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue‑based metrics, contracts, and organizational needs. Other rewards may include annual bonuses, long‑term incentives, paid time off, and region‑specific benefits.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible spending accounts (FSAs)
• Health savings accounts (HSAs)
• Accident insurance
• Pet insurance
• Company‑paid life and accidental death & dismemberment (AD&D) insurance
• Company‑paid long‑term and short‑term disability insurance
• 401(k) with employer match
• Paid time off (PTO)
• Paid holidays

Equal Opportunity Employer

Hydrafacial is proud to be an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, sex, religion, sexual orientation, national origin, gender identity, gender expression, age, disability, genetic information, pregnancy or any other protected characteristic as outlined by law. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.