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

Location : Sandy, UT

Duration : 12 Months Contract

Total Hours/week :40.00

1^st shift

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 includes:

• 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.