Design Quality Engineer I

INOVIO PHARMACEUTICALS INC•San Diego, CA

11d

About The Position

The Design Quality Engineer I plays a key supporting role within the product development organization by maintaining accurate, compliant design control documentation throughout the product lifecycle. 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. This role offers hands‑on experience with medical device compliance frameworks and cross‑functional collaboration.

Requirements

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 preferred).
Ability to work cross‑functionally and manage multiple document workflows.
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)
Comfort with Excel or data tracking tools for logs, metrics, and traceability matrices.
A current US work authorization is required.

Responsibilities

Maintain D&D procedural framework to ensure alignment with QMSR, ISO 14971, ISO 13485, and 21 CFR Part 4 design and risk control requirements.
Review and approve D&D documentation (e.g., design plans, design inputs/outputs, verification/validation records) under supervision.
Ensure Design History File (DHF) completeness, including proper traceability, version control, and accessibility for internal audits and regulatory inspections.
Support cross‑functional teams in preparing documentation for regulatory submissions (FDA, EU MDR, etc.).
Assist in maintaining traceability matrices linking requirements, risks, verification, and validation activities.
Participate in design reviews, capturing minutes, action items, and ensuring documentation accuracy.
Help monitor and update design control metrics, logs, and trackers.
Support continuous improvement of design control processes and templates.