Medical Device R&D Engineer: Usability & V&V Specialist

Highbrow Technology Inc; Menlo Park (CA); Vor Ort; USD 95.000 - 130.000; Vollzeit

Zusammenfassung

Highbrow Technology Inc. seeks an R&D engineer with experience in medical product development, human factors/usability evaluation, anatomical model development, and verification & validation (V&V) testing.

The ideal candidate will work closely with physicians, medical staff, and cross-functional teams including R&D, Marketing, Risk Management, Medical Affairs, Quality, and Regulatory Affairs.

Qualifikationen

• BS Degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science.
• 1+ year of relevant medical product development experience, or a graduate degree with project experience.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.

Aufgaben

• Support usability testing, validation testing, model development, and technical protocol/report writing.
• Evaluate prototypes and simulate/test products to validate intended use requirements.
• Perform laboratory testing, data collection, analysis, and interpretation.
• Support human factors/usability analyses, feasibility studies, technology assessments, concept studies, benchmarking, and submission studies.
• Contribute to verification and validation activities for medical device products and subsystems.
• Analyze data from field studies and research activities.
• Prepare and maintain technical documentation, protocols, and reports.
• Ensure compliance with FDA regulations, Quality Management Systems (QMS), and other applicable regulatory requirements.
• Collaborate effectively with physicians, medical staff, engineers, and cross-functional stakeholders.
• Support additional projects and responsibilities as assigned.

Kenntnisse

Biomedical

Mechanical

Electrical

Biological

Physical Science

Ausbildung

Bachelor's degree in Biomedical, Mechanical, Electrical, Biological, or Physical Science

Jobbeschreibung

Highbrow Technology Inc. seeks an R&D engineer with experience in medical product development, human factors/usability evaluation, anatomical model development, and verification & validation (V&V) testing.

The ideal candidate will work closely with physicians, medical staff, and cross-functional teams including R&D, Marketing, Risk Management, Medical Affairs, Quality, and Regulatory Affairs.