Medical Device Engineer

The Science Team at Pride Health supporting the Pharmaceutical Industry that has an opening for Medical Device Engineer in San Diego, CA.

We are seeking a Senior Medical Device Engineer to join our Research & Development team. In this role, you will collaborate with scientists, engineers, Quality, Manufacturing, and Regulatory teams to develop, optimize, and validate innovative material designs for medical device applications. You will play a key role in supporting product development through hands‑on laboratory work, technical documentation, qualification and validation activities, and cross‑functional collaboration.

Contract Length: 06 Months with the possibility of extensions.
Pay range: $60 to $70 per hour on W2 (As per experience).

• Develop and optimize polymer membrane formulations and material solutions for medical device applications.
• Plan, execute, and analyze laboratory experiments to support product and process development.
• Generate, review, and maintain technical documentation including protocols, reports, SOPs, work instructions, and design control documentation.
• Support qualification and validation activities, including IQ, OQ, PQ, method validation, verification, and process validation.
• Collaborate with cross‑functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and external suppliers.
• Identify, procure, and qualify raw materials to support product development and commercialization.
• Perform risk assessments and support design control activities throughout the product development lifecycle.
• Analyze experimental data using statistical tools and Design of Experiments (DOE) methodologies to drive technical decisions.
• Ensure compliance with FDA regulations, ISO 13485, GxP requirements, and internal quality standards.
• Support commercialization efforts and continuous improvement initiatives.
• Follow laboratory safety procedures, chemical hygiene practices, and environmental health and safety requirements.

• Bachelor's degree in Materials Science, Polymer Science, Chemical Engineering, Biomedical Engineering, Chemistry, or a related engineering or scientific discipline.
• Minimum of 5-7 years of experience in medical device development, materials science, polymer science, biosensor development, or a related field.
• Strong understanding of polymer materials, formulation development, and laboratory experimentation.
• Experience with technical writing and Good Documentation Practices (GDP).
• Experience supporting design controls, qualification, and validation activities in a regulated environment.
• Working knowledge of FDA Quality System Regulations, ISO 13485, and GxP requirements.
• Experience with statistical analysis and DOE methodologies; JMP experience is preferred.
• Proficiency with Microsoft Office applications.
• Excellent written and verbal communication skills.
• Strong analytical, organizational, and problem‑solving abilities.
• Ability to work effectively in a fast‑paced, collaborative environment.

• Experience with Class III medical devices or biosensor technologies.
• Knowledge of risk management and product development lifecycle documentation.
• Experience with supplier qualification and raw material selection.
• Project management experience is a plus.

Must be authorized to work in the United States.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.