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

Company: millenniumsoft
Location: Sandy
Posted on: April 2, 2026

Job Description:

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.

Keywords: millenniumsoft, Logan , Staff Engineer(5 years of design development medical device experience), Engineering , Sandy, Utah