Senior Design Quality Engineer

Hydrafacial LLC; 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 (PTO)

Job summary

Hydrafacial LLC in Long Beach, CA is seeking a Senior Design Quality Engineer responsible for R&D processes and documentation. The role requires a BS in Engineering, 5+ years in a regulated environment, and proficiency in SolidWorks.

Benefits include medical and dental insurance, paid time off, and a 401(k) with employer match. The salary range for this position is between $93,500 and $112,000 plus bonuses.

Qualifications

• 5+ years of experience in writing and leading documentation in a regulated environment.
• Experience with SolidWorks creating 2D drawings.
• Knowledge of standards for Design Controls and generating and maintaining Design History Files.

Responsibilities

• Ensure R&D is following good documentation practices.
• Update R&D procedures to align with latest standards.
• Manage the creation of overarching design control documentation.

Skills

Writing and leading documentation in a regulated environment

SolidWorks

Design Controls (FDA 21 CFR 820.30)

Document control practices

Education

BS degree in Engineering or related technical field

MS in a related technical field

Tools

CAD

SolidWorks

Job description

Description

The Senior Design Quality Engineer is responsible for research, product development, and sustaining engineering documentation.

This is a hybrid role based out of our Long Beach, CA headquarters, with designated in-office collaboration days each week.

What you’ll do

Primary Responsibilities:

• Ensure R&D and other disciplines are following good documentation practices.
• Update existing R&D procedures and forms to align with the latest standard (FDA and ISO) and internal design practices.
• Ensure R&D and other disciplines are following through on design control and other key documentation.
• Manage the creation of overarching design control documentation.
• Assisting in writing requirements, protocols, reports, and other key documentation, as well as 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.

What you need to know

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 creating 2D drawings
• Knowledge of standards for Design Controls (FDA 21 CFR 820.30) 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
• Strong communication and presentation skills.

We mean it when we say you’ll LOVE this role.

Base Pay: $93,500 - $112,000 + bonus

An employee’s pay position within the salary range will be based on several factors, including but not limited to relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, travel requirements, revenue-based metrics, any contractual agreements, and business or organizational needs. The range listed is just one component of HydraFacial’s total rewards package for our employees. Other rewards may include annual bonuses, long-term incentives based on level, paid time off, and region-specific benefits. Come grow and GLOW with us!

What else can you expect with HydraFacial?

Benefits include: Medical insurance, dental insurance, vision insurance, FSAs, HSAs, accident insurance, pet insurance, company-paid life and AD&D insurance, company-paid long-term and short-term disability insurance, 401(k) with employer match, paid time off (PTO), and paid holidays.

Equal Opportunity Employer Statement

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 color, federal, state or local laws. We are committed to working with and providing accommodation to applicants with physical and mental disabilities.