RESPONSIBILITIES:
Kforce's client, a growing and established Medical Device Company is seeking a Senior FDA Design Quality Engineer (SW). We are working directly with the Hiring Managers on these search assignments. This is a client we have worked with for many years. The company offers a competitive compensation including base salary, annual bonus, and Stock/RSUs Plan. This position is 100% Remote.
Responsibilities:
* Senior FDA Design Quality Engineer will work with software teams, RA and NPD teams to ensure that the software projects are meeting regulations and quality standards
* Take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development
* Handle the Design Control process from beginning to end - will handle all 5 steps
* Creates and reviews various software lifecycle project deliverables based on procedural requirements
* Performs risk analysis and is responsible for risk management activities determines, evaluates, and documents software risks from product design to post-launch
* Provides traceability analysis and traceability reports to ensure project requirements have been met
* Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies
* Work with software teams, RA, NPD teams as well as other teams
* As a Senior FDA Design Quality Engineer, you will review and approve CO's as well as provides quality input to support closure (QMS updates, Procedural changes, etc.)
* Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable
* Please note that this role will not be responsible for any software development or software testing; This is an FDA Medical Design Quality Engineering position
REQUIREMENTS:
* BS degree in Engineering, Biotechnology, or Computer Sciences or related field or equivalent combination of education and years of applicable experience
* At least 5-8 years of experience acting as a Medical Device Quality Engineer on software projects and guiding cross-functional teams towards compliance in an FDA-regulated industry
* Strong working experience in Risk Analysis and Risk Management processes
* Experience with the FDA Design Control process is required; Must know at least 4 to 5 steps of the design control process
* Working knowledge of federal and other regulations including QSRs, ISO 14971, IEC 62304 are required
* Skilled at promoting team cooperation and a commitment to team success
* A strong understanding of the Software Development Lifecycle (SDLC)
* Knowledge of mobile app technologies is a plus but not required
* Experience with product launch and product planning is important
The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.
We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.
Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.
This job is not eligible for bonuses, incentives or commissions.
Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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