Design Quality Engineer I
Not Disclosed•Full-TimeOn-site
location_onScranton Road, Sorrento Valley, San Diego, San Diego County, California, 92121, United States
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools.
About the Role
The Design Quality Engineer I plays a key supporting role within the product development organization. This position ensures that design and development activities align with QMSR, ISO 14971, and ISO 13485 requirements, contributing to audit-ready records and robust traceability. The role offers hands-on experience with medical device compliance frameworks and cross-functional collaboration, maintaining accurate, compliant design control documentation throughout the product lifecycle.
Equal Opportunity
INOVIO Pharmaceuticals, Inc. is an Equal Employment Opportunity Employer, including but not limited to veterans and individuals with disabilities. We prohibit discrimination of any kind. In keeping with our policy, we recruit, hire, train, and promote the most qualified individuals for all job titles, and we provide equal opportunities to all employees and applicants for employment.
Important Notice
A current US work authorization is required. INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided.
Work location
Work model: On-site
Scranton Road, Sorrento Valley, San Diego, San Diego County, California, 92121, United States
San Diego, California
Key Responsibilities
- check_circleMaintain design and development procedural framework to ensure alignment with QMSR, ISO 14971, ISO 13485, and 21 CFR Part 4 requirements
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Skills, education and keywords
Skills: Iso 13485, Iso 14971, QMSR, 21 CFR Part 4, Fmea, Hazard Analysis, Veeva, Master Control, Agile PLM, Excel.
Education: Bachelor's degree in engineering, life sciences, or related field required.
Frequently asked questions about Design Quality Engineer I at INOVIO Pharmaceuticals, Inc.
What does a Design Quality Engineer I at INOVIO Pharmaceuticals, Inc. do?expand_more
In this Design Quality Engineer I at INOVIO Pharmaceuticals, Inc. role, you will maintain design and development procedural framework to ensure alignment with qmsr, iso 14971, iso 13485, and 21 cfr part 4 requirements; ensure design history file completeness with proper traceability, version control, and accessibility for audits; maintain traceability matrices linking requirements, risks, verification, and validation activities; and participate in design reviews by capturing minutes, action items, and ensuring documentation accuracy.
What are the requirements for this Design Quality Engineer I role?expand_more
To qualify for the Design Quality Engineer I at INOVIO Pharmaceuticals, Inc. position, applicants should have: Bachelor's degree in engineering, life sciences, or related field; 1-2 years of experience in medical device, biotech, or regulated industry; Basic understanding of medical device regulations (ISO 13485, QMSR/QSR, ISO 14971, 21 CFR Part 4); Basic understanding of risk management tools (e.g., FMEA, hazard analysis); Proficiency with document control or QMS systems (e.g., Veeva, Master Control, Agile PLM); and Comfort with Excel or data tracking tools.