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

Description

• 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
• Provide solid technical skill and engineering support for design and development activities for new and existing products
• Support current products in terms of quality, manufacturing, supply continuity and cost improvement
• Participate in executing technical and/or cross-functional project work
• Contribute to a culture of innovation by proactively generating novel concepts for new products and enhancements to current product performance
• Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies
• Translate customer needs into engineering requirements into specific product, packaging and process specifications
• Engineer robust and manufacture products through strong understanding and application of engineering fundamentals
• Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis
• Write detailed technical reports based on design verification analysis/testing for design changes and product design activities
• Ensure compliance with client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures

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.