The Product Performance Engineer effectively monitors post market product performance, conducts product risk evaluations, supports the complaints handling process and performs case clinical analysis to determine cause of failures. Based on clinical knowledge, support complaints handling process and investigations. This position has the responsibility and authority to support robotics surgical systems through the product life cycle, with primary focus in clinical related complaint handling and investigations during post market monitoring. This position also leads cross-functional team to investigate clinical, software, hardware and all other types related complaints.
Understand the underlying technology of the products.
Support complaint investigations and clinical analysis in accordance with 21 CFR § 820.198 and ISO 13485:2016 8.2.2
Develop, prepare, and analyze product performance trend reports
Communicates results with internal departments, i.e., Product, R&D, RA, and Clinical.
Provides input from PMS to risk management and CAPA.
Actively pursue answers and updates from investigation subject matter experts.
Performs clinical analysis and determines cause of failures
Preforms post market risk assessment
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Bachelor’s degree in scientific area - Must.
2+ years experience working in medical devices industry or similar scientific areas in R&D, PMS or QA functions
Job Specific Skills (Languages, SW, systems, etc.'):
Excellent verbal and written communication skills (Hebrew and English).
Office proficient, experience and understanding of ERP, PLM, LMS, Doc Control systems, experience with Salesforce – Preferred.
Written and verbal communication skills.
Ability to work with a sense of urgency.
Orientation to details.
Able to confidently deal with ambiguous issues and provide input towards suitable actions.