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Healthcare Technology Specialist

2 months ago


Berkeley, California, United States HS Solutions Inc Full time
Position Overview

We are seeking a skilled Biomedical Engineer to join our team at HS Solutions Inc. This role involves a variety of responsibilities aimed at enhancing the quality and performance of medical devices.

Key Responsibilities:
  • Device Development: Engage in the design and improvement of medical devices, focusing on areas such as neurology, drug delivery systems, and robotics.
  • Quality Assurance: Conduct thorough root cause analyses and failure investigations to elevate product quality and minimize defects.
  • Testing and Calibration: Perform extensive characterization, calibration, and quality control testing of electrochemical biosensors.
  • Assay Optimization: Collaborate with point-of-care medical devices to enhance assay performance.
  • Laboratory Management: Oversee laboratory operations and lead cross-functional teams in ongoing assay improvement initiatives.
  • Manufacturing Process Improvement: Analyze electronic LHR systems to identify and resolve manufacturing defects.
  • Validation Processes: Validate manufacturing and R&D equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Documentation Standards: Establish and implement Standard Operating Procedures (SOPs), Manufacturing Work Instructions, Non-Conformance Material Reports (NCMRs), and LHRs in compliance with cGMP, GDP, and ISO13485 standards.
Preferred Skills:

Proficiency in Microsoft Office is considered an advantage.