Position: Quality Engineer (Medical Device & Regulatory)
Location: Phoenix, AZ | SALT LAKE, UT
Duration: 11 months
Essential Skill Skills:
· Proficiency in personal computer software, especially Minitab and Excel. Ability to work in a team. Ability to analyze and evaluate data and recommend actions. Ability to provide inputs for technical reports and protocols. Ability to coordinate test protocols. Ability to work with minimal supervision. Technical writing proficiency. General aptitude with testing and manufacturing equipment. Working knowledge of the theory of operation. Ability to operate laboratory equipment within the area of assigned responsibilities
Roles Description:
· Assists with assignments and is a team member, Performs job with supervision, Develops technician skills. Performs job with accuracy and attention to detail; task oriented, Assists in the generation of formal test protocols and reports, Assists in the execution of test protocols and procedures. Sets up and operates test equipment and records measurements with limited supervision. Maintains accurate data and organizes and presents data in a re-portable format, Provides process/test method training to manufacturing/QC personnel. Develops and maintains a working knowledge of CUSTOMER policies and procedures and ISO and FDA requirements. Expedites and tracks Development Builds through documentation and manufacturing processes. Must be able to work in a bio-hazard environment and comply with safety policies and procedures outlined by CUSTOMER policies.
Desirable Skill:
· Experience working with Venous Catheters, Ports desired, Associates Degree in science, math or engineering and two (2) years of related experience. OR Minimum of (6) six years related experience.
Role : Sr. Medical Device - R & D Engineer
Work Location : Phoenix, AZ & Salt Lake City, UT
Duration of assignment (in Months) : 12 months
Relevant Experience: 4-6 Years
Role Description
Identify all applicable documentation Identify missing documentation Baseline product Testing Creating an assessment of DHF gaps – All gaps are defined DIR and RM updates to support phase two testing Define extent of MDR/Complaint reduction activities that will happen in parallel Establish the detailed project plan Determine if and what MDR/Complaint reduction activities will be pursued with remediation Remediate the gaps Protocols (leverage "predicate" protocols to speed up writing)conditioning Testing Reports Process Validation and Component Qualification work Deliverables updates to reflect remediation activities Launch of any MDR/Complaint reduction changes
Essential Skills
Excellent Knowledge of Medical Device Design Control Requirements Update Design History File and Risk Management File Write Test Protocols and Test Results Good knowledge and understanding of ISO-13485 requirements
Desirable Skills
Experience working with Venous Catheters, Ports desired Minimum of 5 years experience within the medical device industry with a Bachelor's degree or advanced degree (Master's or PhD) plus 3 years of engineering experience within the medical device or equivalent industry.
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