ZipRecruiter

Log In

1

Design Assurance Engineer Jobs in California (NOW HIRING)

Envista

Design Assurance Engineer II

Pomona, CA · On-site

$95K - $116K/yr

The Design Assurance Engineer II supports the development, manufacturing, and lifecycle management of dental consumables by ensuring design control, risk management, quality, and regulatory ...

Vertex Sigma Software

QA Engineer

Foster City, CA · On-site

QA Engineer Onsite in Foster City, CA 5 days in office The Quality Assurance team is actively ... Responsibilities Design and implement test plans and procedures for our backend services, which ...

next page

Showing results 1-20

All JobsDesign Assurance Engineer JobsDesign Assurance Engineer Jobs in California

Design Assurance Engineer information

See California salary details

$17

$50

$72

How much do design assurance engineer jobs pay per hour?

As of Aug 6, 2026, the average hourly pay for design assurance engineer in California is $50.03, according to ZipRecruiter salary data. Most workers in this role earn between $38.65 and $60.96 per hour, depending on experience, location, and employer.

What is a design assurance engineer?

A Design Assurance Engineer ensures that products meet regulatory standards, quality requirements, and design specifications throughout development. They collaborate with design, manufacturing, and quality teams to identify risks, implement process improvements, and ensure compliance with industry standards like ISO 13485 or AS9100. Their role includes risk management, validation, verification, and documentation to ensure product reliability and safety.

What are the key skills and qualifications needed to thrive as a design assurance engineer?

To thrive as a Design Assurance Engineer, you need expertise in quality assurance, regulatory compliance, risk management, and a solid engineering background, typically supported by a bachelor’s degree in engineering or a related field. Familiarity with industry standards such as ISO 13485, knowledge of design control processes, and proficiency in tools like FMEA and statistical analysis software are highly valued, along with certifications such as ASQ CQE. Strong attention to detail, problem-solving, communication skills, and the ability to collaborate across multidisciplinary teams set top candidates apart. These skills ensure products meet regulatory standards and customer requirements while minimizing product risks and ensuring successful project outcomes.

What are the primary responsibilities of a design assurance engineer?

As a Design Assurance Engineer, you are responsible for ensuring that all product design activities comply with regulatory requirements and internal quality standards throughout the development lifecycle. This includes reviewing and approving design documents, participating in risk analyses, ensuring effective implementation of design controls, and collaborating with cross-functional teams such as R&D, manufacturing, and regulatory affairs. You may also be involved in conducting root cause investigations for product non-conformances and supporting audits or inspections. This role is crucial for maintaining product quality and safety, and provides opportunities to work on innovative projects and advance into roles with greater responsibility in quality assurance or regulatory affairs.

What are popular job titles related to Design Assurance Engineer jobs in California? For Design Assurance Engineer jobs in California, the most frequently searched job titles are:
What job categories do people searching Design Assurance Engineer jobs in California look for? The top searched job categories for Design Assurance Engineer jobs in California are:
Design Assurance Engineer jobs near you
Infographic showing various Design Assurance Engineer job openings in California as of August 2026, with employment types broken down into 86% Full Time, and 14% Contract. Highlights an 100% In-person job distribution, with an average salary of $104,055 per year, or $50 per hour.

Design Assurance Engineer - Orthopedic Medical Devices

Stark Pharma Solutions Inc

San Francisco, CA • On-site

Contractor

Re-posted 25 days ago

Job description

Hi,

My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Design Assurance Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.

Role: Design Assurance Engineer – Orthopedic Medical Devices

Location: California
Duration: Long Term

Position Overview

We are seeking an experienced Design Assurance Engineer to support EU MDR remediation and quality initiatives for orthopedic medical device product lines. This role will focus on design assurance activities, technical documentation remediation, risk management, and ensuring compliance with global regulatory requirements throughout the product lifecycle.

The ideal candidate will have a strong background in orthopedic medical devices, design controls, risk management, and EU MDR compliance within a regulated medical device environment.

Key Responsibilities

  • Support EU MDR remediation projects for orthopedic medical device products.
  • Review, update, and maintain Design History Files (DHFs) and technical documentation.
  • Perform design assurance activities across all stages of the product lifecycle.
  • Conduct risk management activities in accordance with ISO 14971 requirements.
  • Execute gap assessments and remediation efforts to ensure EU MDR compliance.
  • Participate in design reviews and support design control activities.
  • Review and update verification and validation documentation.
  • Collaborate with Regulatory Affairs, Clinical Affairs, Manufacturing, R&D, and Quality teams.
  • Support regulatory submissions and responses related to EU MDR requirements.
  • Ensure compliance with FDA regulations, EU MDR requirements, ISO 13485, and applicable quality standards.
  • Drive quality and compliance improvements across product development and remediation initiatives.

Required Qualifications

  • Bachelor's degree in Engineering or a related technical discipline.
  • 5–10+ years of Design Assurance, Quality Engineering, or Medical Device Quality experience.
  • Strong experience within the orthopedic medical device industry.
  • Proven experience supporting design assurance, remediation, or quality engineering projects.
  • Strong knowledge of:
    • Design Controls
    • Risk Management
    • Product Lifecycle Management
    • Technical Documentation
    • Design History Files (DHFs)
  • Working knowledge of:
    • FDA 21 CFR Part 820
    • ISO 13485
    • ISO 14971
    • EU MDR Regulations
  • Experience working within cross-functional product development and quality teams.
  • Excellent communication, technical writing, and documentation skills.

I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.  

Please follow Stark Pharma Solutions on LinkedIn for the latest job updates: https://www.linkedin.com/company/99455976/

Thank you,

Karthik Mutyala

Recruiting Manager

Stark Pharma Solutions Inc

Email: karthik@starkpharma.com

15 Corporate Place S, Suite 350,

Piscataway, New Jersey 08854

www.starkpharma.com