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, Provo , Staff Engineer(5 years of design development medical device experience), Engineering , Sandy, Utah
