Biomedical Engineer Product Development & Field

The Biomedical Engineer will support the design, development, testing, validation, installation, servicing, and continuous improvement of Optra Scan's digital pathology scanners and related medical imaging products. This role combines product engineering with customer-facing field support and requires close collaboration with R&D, Software, Quality, Manufacturing, Regulatory, Sales, and Service teams to ensure successful product deployment, customer satisfaction, and continuous product improvement.

The position involves regular travel to customer sites for system installations, calibrations, demonstrations, preventive maintenance, troubleshooting, and post-sales technical support.

• Support the design, development, and evaluation of digital pathology scanners and related medical device systems.
• Perform hardware integration, calibration, verification, validation, and system performance testing.
• Conduct system troubleshooting, failure analysis, and root cause investigations.
• Prepare engineering documentation, validation protocols, test reports, and technical documentation.
• Participate in design reviews, risk management, design verification & validation, and engineering change activities.
• Collaborate with Software, AI/ML, Mechanical, Electrical, and Optical Engineering teams during product development.
• Work closely with Quality and Regulatory teams to ensure compliance with ISO 13485, FDA, CE, and other applicable standards.
• Support manufacturing during product transfer, process improvements, and production issue resolution.
• Evaluate new technologies and recommend product enhancements based on engineering analysis and customer feedback.

• Travel to customer sites for installation, calibration, commissioning, and validation of digital pathology scanners.
• Provide on-site technical support, troubleshooting, servicing, preventive maintenance, and corrective maintenance.
• Diagnose hardware, software, and system-level issues and coordinate with engineering teams for timely resolution.
• Conduct product demonstrations for prospective customers in collaboration with Sales and Business Development teams.
• Deliver customer training on system operation, maintenance, workflows, and best practices.
• Provide post-sales technical support to ensure successful customer onboarding and product adoption.
• Support customer evaluations, pilot installations, and proof-of-concept studies.
• Maintain detailed service reports, installation documentation, and customer visit records.
• Act as the technical liaison between customers and internal engineering teams, communicating field feedback to support continuous product improvement.

• Bachelor's or Master's degree in Biomedical Engineering.
• 1–7 years of experience in medical devices, diagnostics, healthcare technology, or biomedical instrumentation.
• Experience with installation, servicing, calibration, or field support of medical devices is preferred.
• Knowledge of medical imaging systems, optics, sensors, biomedical instrumentation, and hardware troubleshooting.
• Understanding of design controls, verification & validation, and risk management principles.
• Familiarity with ISO 13485, ISO 14971, IEC 60601, FDA Quality System Regulations, and other relevant medical device standards.
• Strong analytical, documentation, troubleshooting, and problem-solving skills.
• Excellent communication and customer-facing interpersonal skills.
• Willingness to travel extensively (domestic and international) for customer installations, demonstrations, servicing, and technical support.
• Ability to work independently at customer sites while collaborating effectively with cross‑functional teams.