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Design Quality Engineer Jobs (NOW HIRING)

Enovis

Design Quality Engineer

Carlsbad, CA · On-site

Design Quality Engineer Reports To: Director, QA | QC Location: Carlsbad, CA (Hybrid 3 days onsite 2 days remote) Business Unit Description: Bracing & Supports Job Title/High-Level Position Summary:

Enovis

Design Quality Engineer

Carlsbad, CA · Hybrid

Design Quality Engineer Reports To: Director, QA | QC Location: Carlsbad, CA (Hybrid 3 days onsite 2 days remote) Business Unit Description: Bracing & Supports Job Title/High-Level Position Summary:

AIT Global, Inc.

Design Quality Engineer

Danbury, CT · On-site

Design Quality Engineer Location: Danbury, CT Position Overview: We are seeking a hands-on Design Quality Engineer to support product quality, root cause investigation, and corrective action ...

Philips

Design Quality Engineer

Bedford, MA · On-site

$103K - $163K/yr

Job Title Design Quality Engineer The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products.

Noblesoft Technologies

Design Quality Engineer

Plano, TX · On-site

$40 - $45/hr

Design Quality Engineer Location: Plano, TX (onsite) Customer: Abbott Laboratories JD: * 6+ years of Medical devices - Design Quality experience for the projects related to Design Change, Clinical ...

Philips

Design Quality Engineer

Bedford, MA

$103K - $163K/yr

Job TitleDesign Quality Engineer The Design Quality Engineer is accountable for design quality, risk management, sustaining and complaint investigations for Philips Image Guided Therapy products.

Abbott

Design Quality Engineer

Irving, TX

$68K - $136K/yr

Design Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access ...

Abbott

Design Quality Engineer

Irving, TX · On-site

$68K - $136K/yr

Design Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access ...

Abbott

Design Quality Engineer

Irving, TX · On-site

$68K - $136K/yr

Design Quality Engineer Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access ...

avalign

Sr. Design Quality Engineer

Fort Wayne, IN

The Design Quality Engineer will be responsible for the quality and regulatory related activities associated with new product development. New product development activities will occur in the ...

CONMED

Design Quality Engineer II

Utica, NY

$74K - $115K/yr

The Design Quality Engineer II is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities.

QUANTERIX CORP

Lead Design Quality Engineer

Billerica, MA · On-site

$125K - $150K/yr

Lead Design Quality Assurance Engineer Billerica, Massachusetts Quanterix is revolutionizing biomarker analysis to advance precision health, leveraging Simoa technology for ultra-sensitive protein ...

Collabera

Design Quality Engineer

Plymouth, MN

... Quality Engineering in the medical device industry (or related industry). Familiar with critical elements of the design history file including risk management, design verification and validation ...

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Design Quality Engineer information

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How much do design quality engineer jobs pay per hour?

As of Jul 17, 2026, the average hourly pay for design quality engineer in the United States is $47.19, according to ZipRecruiter salary data. Most workers in this role earn between $38.70 and $56.49 per hour, depending on experience, location, and employer.

How does a Design Quality Engineer typically collaborate with cross-functional teams during product development?

As a Design Quality Engineer, you work closely with teams such as R&D, manufacturing, regulatory affairs, and supply chain throughout the product development lifecycle. Your primary role is to ensure quality standards are integrated from the initial concept through to product launch. This often involves participating in design reviews, facilitating risk assessments like FMEA, and ensuring compliance with relevant regulations. Effective communication and problem-solving skills are essential, as you'll help bridge gaps between design intent and manufacturability to ensure a smooth transition to production.

What are the key skills and qualifications needed to thrive as a Design Quality Engineer, and why are they important?

To thrive as a Design Quality Engineer, you need a solid background in engineering principles, quality assurance methodologies, and a relevant degree such as mechanical or electrical engineering. Familiarity with standards like ISO 13485 or ISO 9001, proficiency in tools such as FMEA, risk analysis software, and statistical analysis platforms like Minitab are typically required. Strong problem-solving abilities, attention to detail, and effective communication skills help distinguish top performers in this role. These skills ensure that products meet regulatory requirements, maintain high quality standards, and minimize risk throughout the design and development process.

What are Design Quality Engineers?

Design Quality Engineers are professionals who ensure that products are developed and manufactured according to quality standards and regulatory requirements. They work closely with design, engineering, and manufacturing teams to identify potential risks, implement quality controls, and validate product designs. Their goal is to make sure that products are safe, effective, and meet customer expectations before they are released to the market.

What is the difference between Design Quality Engineer vs Manufacturing Quality Engineer?

AspectDesign Quality EngineerManufacturing Quality Engineer
Primary FocusEnsuring product design meets quality standards and specifications during developmentMonitoring and improving quality in manufacturing processes and final products
Work EnvironmentDesign labs, R&D departments, product development teamsProduction lines, manufacturing plants, quality control departments
Required CredentialsBachelor's in Engineering, Quality certifications (e.g., CQE), knowledge of design standardsBachelor's in Engineering or Manufacturing, Quality certifications, process improvement skills

Design Quality Engineers focus on product design and development to prevent defects early, while Manufacturing Quality Engineers concentrate on maintaining quality during production. Both roles require similar credentials and work within quality assurance but target different stages of the product lifecycle.

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Design Quality Engineer jobs near you
Design Quality Engineer

Design Quality Engineer

Enovis

Carlsbad, CA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 24 days ago

Enovis rating

8.8

Company rating: 8.8 out of 10

Based on 23 frontline employees who took The Breakroom Quiz

Job description

Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
What You'll Do
At Enovis™ we pay attention to the details. We embrace collaboration with our partners and patients, and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself.
As a key member of the Quality Design Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.
Job Title:
Design Quality Engineer
Reports To:
Director, QA | QC
Location:
Carlsbad, CA (Hybrid 3 days onsite 2 days remote)
Business Unit Description:
Bracing & Supports
Job Title/High-Level Position Summary:
The Design Quality Engineer position is responsible to implement and lead Design Quality Engineering activities at the Enovis design and production location(s) as assigned. The Design Quality Engineer will support priority Product Development and Sustaining Design Engineering projects as the lead Quality Engineering technical representative. This position will be responsible to assure product designs meet our compliance with FDA regulations, ISO 13485 and global regulatory standards and Company strategies. The position will report directly to the Manager of Design Quality.
Key Responsibilities:
  • Assists process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing and design processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements.
  • Support Design Quality Engineering Assignments, including New Product Introduction (NPI) projects, Corporate priority projects and sustaining support. Quality Engineering Responsibilities may include:
    • Support, Review and Approve Design Specification packages
    • Support, Review and Approve Material and Product Test Plans
    • Review and Approve Design Engineering Drawings
    • Review and Approve Design Verification and Validation Test Protocols and Reports
    • Support Design Transfer activities: Develop inspection and testing methods, plans to perform First Article Approvals and lead execution of First Article inspections.
  • Support Sustaining Design Quality Engineering Assignments, including ensuring verification and validation for design changes for product and process improvements, component end of life transition, and quality improvements.
  • Lead Risk Management process for assigned products and projects, coordinating development and implementation of risk management plans, hazard analyses, design and process failure modes and effects analyses (as applicable).
  • Support Design History File establishment, creation, approval and maintenance
    • Perform Design History File audits at Phase Gates to ensure product development projects are in compliance to applicable design control regulations and company policies and procedures.
  • Coordinate Supplier Approvals for NPI projects with Supplier Quality Assurance in accordance with Enovis Supplier Approval process.
  • Support, Review and Approve Design Transfer activities to ensure design quality performance requirements are properly transferred, which may include IQ, OQ, PQ, Process Validation, and updated Inspection Plans.
  • Attend and support Project team meetings, collaboration sessions and other collaboration activities.
  • Review and approve Change Orders required by process owners to write and issue procedures to assure compliance with the current FDA QSR regulations, ISO 13485, CMDR and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary. By the way of example and not exclusion, process may include Standard Operating Procedures (SOP's) manufacturing processes, inspection procedure and test procedures. Review and approve completed procedures to assure compliance with content and regulatory requirements.
  • Support Design Review and Change review meetings; review and decide disposition of obsolete revision materials.
  • Support Cost of Poor Quality Initiative, by developing and executing site projects to reduce the costs associated with poor quality
  • Support Enovis Corrective and Preventive Action Process
    • Lead Supplier Corrective Action program, communicating and coordinating CAPA completion of suppliers.
    • Review CAPA assignment responses for completeness and validity.
    • Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.
  • Conduct internal audits:
    • Conduct interviews, summarize observations, conduct closing meeting with Department Supervisors
    • Enter non-compliances into the Agile system and trend software, and follow-up with process owners until CAPA is closed.
  • Assist in Notified Body Audits, FDA inspections and other 3rd party audits.
  • Performs other duties as assigned by Management.

Minimum Basic Qualifications:
  • Bachelor's degree in Science or Engineering and 3 plus years of experience (CQA or RABQSA, CQE or CMfgE certification required)
  • Requires certification to perform audits. Certification may be obtained through successful completion of an RAB auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor.
  • Requires experience necessary to demonstrate the capability to carry out specialized technical/trade/craft procedure. May require regular use of speaking skills to discuss/explain semi-complex information or writing skills to communicated standard matters or procedures.
  • Requires experience in biomedical engineering standards and concepts. Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards.
  • Requires basic knowledge of manufacturing processes (and associated tools, instruments and test equipment) to include inspection, machine shop technology, polish/grind and clean room technology.
  • To perform this job successfully, an individual should have knowledge of Microsoft Word, or equivalent word processing software; Excel, or equivalent spreadsheet software. Statistical analysis and data base searches.

Desired Characteristics:
  • Competent working knowledge of US and EU quality system regulations.
  • Proven project management skills; able to complete technical projects with minimal supervision. Strong interpersonal communication and teamwork skill.
  • Ability to understand and interpret drawings and data - GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs.

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.
What does creating better together mean to us at Enovis? Discover the "why" behind our purpose, values and behaviors:
Our Enovis Purpose, Values and Behaviors on Vimeo
We offer a comprehensive benefits package that includes:
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Spending and Savings Accounts
  • 401(k) Plan
  • Vacation, Sick Leave, and Holidays
  • Income Protection Plans
  • Discounted Insurance Rates
  • Legal Services

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

What Enovis employees say

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About ENOVIS

Sourced by ZipRecruiter

Industry

Health care and social assistance

Company size

5,001 - 10,000 Employees

Headquarters location

Wilmington, DE, US

Year founded

1995

Social media

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