Sr. Medical Device Engineer (W2 Only)

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

  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click 
   
  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 $65.00/hr - $68/hr.