Job Title: Quality Engineer
Reports to: Design Center Director
Department: Design Services
The Product Verification Engineer is responsible for ensuring that products and engineering solutions developed will comply with requirements established by the customer, international statutory and regulatory sources, and ISO 14071-compliant risk management processes.
- Author and execute design verification, environmental and reliability test protocols for ISO 9001 or ISO 13485 projects.
- Develop and manage product bill of materials and assembly documentation.
- Use electronic test equipment to perform product testing.
- Track and maintain laboratory test equipment and calibration records
- Conduct and support prototype builds.
- Preform life cycle and environmental compliance analysis.
- Provide sustaining engineering manufacturing customers.
- Create and consistently improve project documentation in accordance with the quality management system, ensure that documentation is organized and archived as required.
- Ensure product requirements are clear, concise, and testable; and establish and maintain requirements traceability to verification activities.
- Surface mount and thru-hole PCBA rework.
- Participate in Corrective and Preventive Action Process to continually improvement of the quality management system through the identification of improvement activities, root cause analysis of problems, and application of improvement tools to prevent reoccurrence of problems.
- Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree in Engineering or equivalent combination of education and experience
- Minimum five years previous experience in a quality regulated environment
- Knowledge of ISO 13485, 21 CFR 820 and ISO 14971 regulatory standards
- Understanding of regulatory requirements for design & development and manufacturing of class 2 and 3 medical devices
- Previous experience in product development and manufacturing on electro-mechanical devices
- Knowledge of Reliability Engineering concepts and methods, as well as statistical methods is a plus
To perform the job successfully, an individual should demonstrate the following competencies:
- Design – Generates creative solutions; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
- Problem Solving – Identifies and resolves problems in a timely manner; Develops alternative solutions; Works well in group problem solving situations.
- Technical Skills – Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
- Customer Service – Responds promptly to customer needs; Meets commitments.
- Team Work – Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit.
- Quality Management – Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
This job has no supervisory responsibilities.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must occasionally lift and/or move up to 25 pounds.
While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms and stoop, kneel, crouch, or crawl.
Golden, Colorado 80401
Electronic and Other Electrical Equipment and Components/ and Supplies
APPLY FOR JOB