Product Engineer

Essential Responsibilities

• Diagnose and investigate field issues arising out of customer complaints.
• Solve product safety, quality & performance issues experienced in the clinical environment with thorough root cause analysis.
• Track status and communicate progress effectively to the IB engineering leader by working with customers, supplier quality, manufacturing, field service, complaint handling team and engineers to understand the clinical and other circumstances that may have contributed to the issue.
• Participate in reviewing closure criteria for complaints and continuously work to improve the process alongside complaint handling team.
• Perform data analysis to characterize issues within our product portfolio and to direct design and process changes to improve our products.

Qualifications/Requirements

• BS in Engineering (any discipline) or equivalent experience (defined as a High School Diploma/GED and 4 years’ experience in medical device industry).
• Proven ability to lead, influence, and partner effectively in a manner that supports a diverse global, collaborative, and cross-functional environment.
• Proven analytical, interpersonal, communication, organization, planning and leadership skills.
• Process focus and continuous improvement orientation.

Desired Characteristics

• Two years’ engineering experience in medical device industry or equivalent safety critical industry.
• Familiarity with IEC60601-1 and particular standards for patient parameters.
• Familiarity with ISO 13485 or 21 CFR related regulations.
• Self-starter, energizing, results oriented, and able to multi-task.
• Excellent teamwork, coordination and communication skills.
• Effective oral and written communication skills.
• Global project experience.
• Circuit design and simulation tool experience.