Staff Quality Engineer - Software

Staff Quality Engineer - Software - Design Assurance

Company :

Our client is a well funded startup company in the medical robotics space. They currently have a successful commercial product with several new exciting products in their pipeline.

Target Background :

• BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
• Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years of Engineering work experience with a PhD in the medical device or similarly regulated industry.
• Preferred : minimum of 3 years experience in a development QE function in a regulated environment
• Experience in meeting Design Control and DHF requirements with NPD teams.
• Well versed in the complete Quality Management System to meet US FDA and ISO requirements with an emphasis on IEC 62304.
• Experience with Risk Management, FMEA, Hazard Analysis.
• Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM / eQMS systems.
• Must be a self-starter, team builder, and excellent in verbal and written communication.
• Preferred : Certifications : CQE, CQA(BM), CQM, 6 Sigma, etc.
• Preferred : experience with statistical skills to define / train on test sample size and data analysis techniques.

Job Responsibilities :