Location: Oro Valley, AZ
Pay: $0.00 - $30.00 /Hour
Name: Chelsea Melvin
- The Systems Engineer will be engaged in product risk management (safety) activities and verification of instrument designs according to FDA requirements and internal quality procedures.
- This role will provide input to what is required to show compliance, including the amount of data required and the methodologies for collecting and analyzing the data.
- Ensures that the data is collected using devices and software of appropriate recorded configurations, performs the required analyses, and documents work to meet standards and project delivery commitments.
- Collaborating with project team members to update and evaluate product risk documentation.
- Review use cases and requirements for products to ensure that requirements and specifications can be verified, including risk mitigations, usability and regulatory requirements.
- Project deliverables may including producing and/or reviewing verification plans, protocols, and reports; execution of the plans and protocols; and resolving deviations.
- Conducting formative usability evaluations, developing usability plans, and creating use scenarios.
- A successful candidate will be well versed in Design Controls, ISO 14971 - Medical Device Risk Management, and preferably ISO 62366 - Usability Engineering.
- Experience working in a quality system regulated environment, preferably ISO 13485 and/or 21 CFR 820.
- Writing and executing design verification plans, and protocols.
- Applying Product Risk Management (ISO 14971) during product development.
- Developing Medical equipment or other equipment involving complex, multi-component systems.
- Application of ISO 62366 - Usability Engineering for Medical Devices
- Usability Engineering planning and reporting
- Developing Use Scenarios
- Identifying hazard related use scenarios
- Leading and documenting formative usability evaluations
- Use of requirements / verification test management software (HPQC, DOORS, etc.)
- Experience with the application of EU standards in product development.
- The position requires the candidate to be an excellent communicator who is flexible to changing priorities.
- BS in Engineering (Systems, Mechanical, Electrical, Chemical, Bio/Bio-Medical) or equivalent work experience.
Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.