Title: Sr. Medical Device Engineer
Location: San Diego, CA 
Duration: 6 months (Possibility of extension OR conversion)
 
Day to Day Responsibilities:

• Develop and optimize polymer membrane formulations for biosensor applications.
• Plan, execute, and analyze laboratory experiments to support product and process development.
• Generate and maintain technical documentation including protocols, reports, SOPs, work instructions, and design control documents.
• Support qualification and validation activities including IQ, OQ, PQ, method validations, and verification testing.
• Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory Affairs, and suppliers.
• Identify, procure, and qualify raw materials and manage supplier relationships.
• Perform risk assessments and support product development through design controls and risk management activities.
• Analyze experimental data using statistical tools and DOE methodologies to drive development decisions.
• Ensure compliance with FDA, ISO 13485, and GxP requirements.
• Support commercialization activities and continuous improvement initiatives for biosensor products.

 
Work related years of experience

• Minimum 5-7 years of experience in Medical Device Development, Materials Science, Polymer Science, Chemical Engineering, Biosensor Development, or a related engineering field.
• Experience in regulated environments, design controls, validation, qualification activities, and technical documentation is highly preferred.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $60.00/hr - $65.09/hr.