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.