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.
Applicant Notices & Disclaimers
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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.
