Job Openings >> Staff Engineer(5+ years of design development medical device experience)
Staff Engineer(5+ years of design development medical device experience)
Summary
Title: Staff Engineer(5+ years of design development medical device experience)
ID:157830
Department:Development
Description

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

Location : Sandy, UT

Duration : 12 Months Contract

Total Hours/week :40.00

1st 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.

 

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