You haven't searched anything yet.
Duration: 6 Months
Location: Draper, UT
Max Pay: $37.00-$44.04/hour
Position Summary:
The NPD Quality Engineer (QE) will provide support for several new transcatheter heart valve development projects focusing on risk management, test method development, and inspection methodologies. This includes close coordination with manufacturing in the clean room for R&D builds as well as lab activities for design verification testing with R&D. The QE will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
Key Responsibilities:
* Apply knowledge of quality engineering principles and methods to ensure compliance with Edwards Quality System and also Regulatory requirements. Focus on design control, design verification/validation, FMEA, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies
* Provide assistance to subject matter experts (SME) for responsible product/project within the overall manufacturing and processing of pericardial tissue heart valve assembly, including leveraging of key knowledge of quality engineering principles
* Review design changes; partner with R&D in the design of safe and effective THV devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of clinical devices
* Optimize manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
* Develop basic experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports and lead team members to drive project completion
* Investigate basic manufacturing product quality and compliance issues (e.g. CAPA, NCR, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
* Identify opportunities for design and/or manufacturing transformation in a manner that ensures product development continues to evolve and improve
* Assist with developing technical content of risk management files
* Assist with developing training and documentation materials for production (e.g., inspection documents) to enable the seamless knowledge transfer of project and manufacturing processes from NPD to Operations
Required Qualifications:
* Bachelor's or Master's degree in Engineering or Scientific field
Preferred Qualifications:
* Engineering degree
* Engineering/Internship experience within a medical device industry or highly regulated environment
* Quality Engineering experience in New Product Development.
* Experience providing support for either Design Assurance, Design Controls, Verification & Validation, and/or Test Method Development
* Class III new product development experience
* Knowledge of and experience with Risk Management (i.e. dFMEAs and/or pFMEAs), and reviewing or updating risk management documents.
* Knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Contractor
Business Services
$93k-110k (estimate)
06/06/2024
07/03/2024
ultimatestaffing.com
LAWRENCEVILLE, GA
500 - 1,000
2012
TIM CHRISTY
<$5M
Business Services
Ultimate Staffing provides administrative, clerical, customer service and light industrial staffing services on a project or full-time basis. We are the preeminent staffing services company, recognized as a creative industry leader, equally fulfilling the diverse needs of our customers, Ambassadors and coworkers.
The job skills required for Quality Engineer include Product Quality, Initiative, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Engineer positions, which can be used as a reference in future career path planning. As a Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Engineer. You can explore the career advancement for a Quality Engineer below and select your interested title to get hiring information.