What are the responsibilities and job description for the Remote Med Device SW Design Quality Engineer position at Kforce Inc?
Responsibilities
Kforce's client, a growing and established Medical Device Company is seeking a Remote Mid-level Medical Device Software Design Quality Engineer. 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:
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.
By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
Kforce's client, a growing and established Medical Device Company is seeking a Remote Mid-level Medical Device Software Design Quality Engineer. 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:
- Medical Device Software 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 Medical Device Software 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
- BS degree in Engineering, Biotechnology, or Computer Sciences or related field or equivalent combination of education and years of applicable experience
- At least 2-4 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 3 to 5 steps of the design control process
- Experience with product launch and product planning is important
- 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
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.
By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers. Note that if you choose to communicate with Kforce via text messaging the frequency may vary, and message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You will always have the right to cease communicating via text by using key words such as STOP.
