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General Info
Employer: Pinnacle Recruiting Group Inc.
Location: Salt Lake City, Utah
Job Type: - Biomedical/Biosystems EngineeringLocation: Salt Lake City, Utah
Salary Range: $75,000 to $95,000
Experience Required: 6-7 years
Description
This position is responsible for system development and improvement along with managing projects with divisional impact.
Quality Focus
Responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will support Manufacturing, New Product Development, and Regulatory to ensure systems are in compliance with all internal and external guidelines.
This position reports to a Manager in any of our Engineering areas. This position may supervise technician and other engineers.
Potential Task Assignments within the scope of this position:
1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
4. Provides technical support on components, material methods, systems and equipment.
5. Develops physical and functional test requirements to assure specifications & regulations are met.
6. Writes and approves protocols, reports and data.
7. Manages testing outlined in protocols and test methods
8. Manages/develops validation studies on equipment & processes
9. Conducts complaints investigations
10. Executes design controls
11. Participate in collecting/developing and analyzing design inputs
15. Plans and coordinates engineering test builds.
16. Analyzes problems in design, process and test development. Recommend/implement solutions.
17. Experienced with CAPA (corrective and preventative actions)
18. Experienced dealing with customer complaints and recalls
MINIMUM QUALIFICATIONS:
This position requires:
- Bachelor degree in science or engineering with 10+ years experience within the medical device or equivalent Masters strongly preferred.
Quality Focus
Responsible for systems assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Will support Manufacturing, New Product Development, and Regulatory to ensure systems are in compliance with all internal and external guidelines.
This position reports to a Manager in any of our Engineering areas. This position may supervise technician and other engineers.
Potential Task Assignments within the scope of this position:
1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation
4. Provides technical support on components, material methods, systems and equipment.
5. Develops physical and functional test requirements to assure specifications & regulations are met.
6. Writes and approves protocols, reports and data.
7. Manages testing outlined in protocols and test methods
8. Manages/develops validation studies on equipment & processes
9. Conducts complaints investigations
10. Executes design controls
11. Participate in collecting/developing and analyzing design inputs
15. Plans and coordinates engineering test builds.
16. Analyzes problems in design, process and test development. Recommend/implement solutions.
17. Experienced with CAPA (corrective and preventative actions)
18. Experienced dealing with customer complaints and recalls
MINIMUM QUALIFICATIONS:
This position requires:
- Bachelor degree in science or engineering with 10+ years experience within the medical device or equivalent Masters strongly preferred.
Qualifications
Bachelors in Engineering and 5-10 years experience in Quality in a Medical Device environment.
