Design Quality Engineer

Position: Design Quality Engineer I
# Design Quality Engineer IApply
** Job#: 3058490
***
* Job Description:

** Design Quality Engineer I
*
* Location:

** Remote

Role Overview This organization is seeking a Design Quality Engineer I to partner with R&D on new product development and sustaining engineering activities for a specialized medical device product line. The successful candidate will provide independent Design Quality guidance and review, ensuring design controls, documentation, and verification activities comply with applicable medical device regulations and quality standards.

Key Responsibilities
* Partner with R&D and cross-functional teams throughout new product development and sustaining engineering activities.
* Provide Design Quality guidance and review Design History File (DHF) documentation for completeness, traceability, and compliance.
* Review design inputs and outputs to ensure requirements are clear, testable, traceable, and appropriately linked to user needs, regulatory requirements, and risk controls.
* Review verification and validation (V&V) plans, protocols, and reports, including test methods, acceptance criteria, sample-size/statistical rationale, deviations, results, and conclusions.
* Participate in formal design reviews as the independent Quality representative and identify gaps requiring action.
* Support risk management activities, including hazard analyses and Failure Mode and Effects Analyses (FMEAs), ensuring risk controls are incorporated into design requirements.
* Review engineering design changes and sustaining activities for impacts to requirements, risk, V&V, traceability, and documentation.
* Support design validation, usability/human factors, and design transfer activities.
* Review supplier and external laboratory testing used as V&V evidence.
* Use complaint, nonconformance, CAPA, and post-market data to support sustaining design, risk management, and continuous improvement.

Required Qualifications
*
* Education:

** Bachelor's degree or higher in Engineering or a related technical field, such as Biomedical, Electrical, Systems, or Mechanical Engineering.
*
* Experience:

** Minimum of 3 years of experience in the medical device industry, with hands-on experience in design controls, DHF documentation, and new product development or sustaining engineering.
** Technical

Skills:

** Practical experience developing or reviewing design verification and validation plans, protocols, and reports. Demonstrated knowledge of requirements traceability, acceptance criteria, test methods, sample-size/statistical rationale, deviations, and technical conclusions.

Preferred Qualifications
* Working knowledge of medical device regulations and standards, including 21 CFR Part 820, FDA Quality Management System Regulations, ISO 13485, EU MDR, and ISO 14971.
* Practical understanding of statistical methods used in V&V, including confidence/reliability concepts, measurement systems, and measurement uncertainty.  
* Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

Our commitment to excellence is reflected in many awards, including Clearly Rateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.
** Everforth Apex uses a virtual recruiter as part of the application process. Click  here for more details. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Everforth Apex and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages.

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** Everforth Apex Benefits Overview:
Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a Support Linc Employee Assistance Program…