Staff Engineer5 years of design development medical device experience
Staff Engineer5 years of design development medical device experience
Posted on :
05-04-2025
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1 Vacancy
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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
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 crossfunctional 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: TAA 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 crossfunctional 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 setup 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.
Required Experience:
Staff IC
Employment Type
Full-Time
Key Skills
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