Staff Engineer(5+ years of design development medical device experience)

Description

This position will provide project leadership in DHF remediation activities for Class I and Class II medical devices.

A minimum of 5+ years of design development medical device experience is required (design controls and documentation in a technical project leadership role).

Ability to work onsite (Salt Lake City) in cross-functional R&D role with Quality, Regulatory, Manufacturing, and Marketing resources (some of them being offsite).

Project Scope

• Review of existing DHFs; additional DHF Assessments to determine final gaps per client Quality System
• Review of Applicable Standards and EU MDR requirements
• Establish Remediation Plans for DHF & EU MDR deliverables
• Development of Traceability Documents (design verification protocols/reports, risk management plans)
• Quality Plan closures as appropriate (DV: T=AA, RTA may extend beyond Target Date for project closure)
• Facilitation of Packaging, Sterilization, and Biocompatibility testing through client Centers of Excellence and Resources.

Qualification & Skills

• BS degree in engineering is required (Mechanical or Biomedical Engineering preferred).
• Design Control medical Device Experience
• 5+ years of engineering experience is required, preferably in medical devices.
• Demonstrated ability to utilize statistical tools and computer analysis.